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Professor John Simes

BSc (Med), MBBS, FRACP, SM (Harvard), MD

Professor of Clinical Epidemiology, University of Sydney
Co-Director, Cancer Trials
Senior Associate Director, NHMRC Clinical Trials Centre (FMH)
NHMRC Senior Principal Research Fellow
Medical Oncologist, Royal Prince Alfred Hospital &
Chris O'Brien Lifehouse

Phone

+61 2 9562 5000

Fax

+61 2 9565 1863

john.simes@sydney.edu.au

Biographical details

Professor John Simes AO is a Senior Principal Research Fellow and Senior Associate Director at the NHMRC Clinical Trials Centre (CTC) and Co-Director of Cancer Trials. He was the Founding Director of the CTC for a period of 33 years.

Research interests

At the NHMRC CTC, Professor Simes co-leads a team of researchers that have collaborated on over 100 multicentre clinical trials with 70,000 participants, resulting in major advances in health care. He has played key roles in: (a) the LIPID trial demonstrating survival benefits with pravastatin in 9,014 patients with CHD, which changed national and international guidelines; (b) the FIELD trial demonstrating fenofibrate-associated reductions in microvascular complications in 9,795 patients with diabetes; (c) multiple clinical trials in breast, gastro-intestinal, genitourinary and other cancers that assessed chemotherapy, radiation therapy, surgery and novel targeted therapies and have influenced current practice and ongoing research; (d) studies evaluating optimal use of treatments in neonatal medicine including the BOOST-2 trial; and (e) the demonstration that aspirin is effective and cost-saving in preventing recurrent venous thrombo-embolic disease.

He has been a joint coordinator of the Cholesterol Treatment Trialists Collaboration, which conducts periodic meta-analyses to address key uncertainties about the effects of lowering cholesterol. He is Chair of the INSPIRE (International Trials of Aspirin to Prevent Recurrent Venous Thrombo-embolism) Steering Committee. As Group Coordinator of the Australasian Gastro-Intestinal Trials Group, he is overseeing several GI trials including two large trials on gastro-oesophageal cancer (INTEGRATE and TOPGEAR), and as well as a study of laparoscopic vs open surgical resection for primary rectal cancer (AlaCaRT).

Awards and honours

2020 - Order of Australia

2010 – MOGA Cancer Achievement Award

2009 – Harvard Biostatistics Alum Award

1999 – R.T. Hall Prize, Cardiac Society of Australia and New Zealand. Awarded to LIPID Study Group

1988 – Peter Bancroft Prize for Medical Research, University of Sydney

1975 – Albert Himp Memorial Prize for Gynaecology, Mabel Elizabeth Lever Memorial Prize for Obstetrics, University of Sydney

Cancer

Current research students

Project title	Research student
Bridging the efficacy-effectiveness gap in lung cancer: Using real-world data to inform future research, healthcare policy and clinical practice	Janene DALRYMPLE

Publications

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Book Chapters

Gebski, V., Keech, A., Simes, R. (2007). Applying subgroup analysis to individual patient decisions. In Anthony Keech, Val Gebski, Rhana Pike (Eds.), Interpreting and reporting clinical trials: a guide to the CONSORT statement and the principles of randomised controlled trials, (pp. 114-122). Sydney: AMPCo.

Journals

Mersiades, T., Solomon, B., Thomas, D., Lee, C., Parry, M., Sebastian, L., Ballinger, M., Collignon, E., Turnbull, O., Yip, S., Morton, R., Brown, C., Itchins, M., Simes, R., Pavlakis, N., et al (2024). ASPiRATION: Australian observational cohort study of comprehensive genomic profiling in metastatic lung cancer tissue. Future Oncology, 20(7), 361-371. [More Information]
Brown, B., Galpin, K., Simes, R., Boyer, M., Brown, C., Chin, V., Young, J. (2024). Development of clinically meaningful quality indicators for contemporary lung cancer care, and piloting and evaluation in a retrospective cohort; experiences of the Embedding Research (and Evidence) in Cancer Healthcare (EnRICH) Program. BMJ Open, 14(2), e074399. [More Information]
Dakic, A., Wu, J., Wang, T., Huynh, K., Mellett, N., Duong, T., Beyene, H., Yang, J., Figtree, G., Simes, R., et al (2024). Imputation of plasma lipid species to facilitate integration of lipidomic datasets. Nature Communications, 15(1), 1540. [More Information]
Mihaylova, B., Wu, R., Zhou, J., Williams, C., Schlackow, I., Emberson, J., Reith, C., Keech, A., Robson, J., Simes, R. (2024). Lifetime effects and cost-effectiveness of standard and higher-intensity statin therapy across population categories in the UK: a microsimulation modelling study. The Lancet Regional Health. Europe, 40, 100887. [More Information]
Wu, R., Gray, A., Simes, R., Baigent, C., Mihaylova, B., Williams, C., Zhou, J., Schlackow, I., Emberson, J., Reith, C., Keech, A., et al (2024). Long-term cardiovascular risks and the impact of statin treatment on socioeconomic inequalities: a microsimulation model. British Journal of General Practice, 74(740), e189-e198. [More Information]
Vasconcelos, J., Moore, M., Karapetis, C., Siu, L., Shapiro, J., Simes, R., Gill, S., O’Callaghan, C., Loree, J., Chen, N., et al (2024). Transverse Colon Primary Tumor Location as a Biomarker in Metastatic Colorectal Cancer: A Pooled Analysis of CCTG/AGITG CO.17 and CO.20 Randomized Clinical Trials. Clinical Cancer Research, 30(6), 1121-1130. [More Information]
Campbell, I., Wetzig, N., Ung, O., Espinoza, D., Farshid, G., Collins, J., Kollias, J., Gebski, V., Mister, R., Simes, R., Stockler, M., et al (2023). 10-Year axillary recurrence in the RACS SNAC1 randomised trial of sentinel lymph node-based management versus routine axillary lymph node dissection. Breast, 70, 70-75. [More Information]
Thavaneswaran, S., Kansara, M., Lin, F., Espinoza, D., Grady, J., Lee, C., Ballinger, M., Sebastian, L., Corpuz, T., Qiu, M., Bailey, C., Schmitz, U., Simes, R., et al (2023). A signal-seeking Phase 2 study of olaparib and durvalumab in advanced solid cancers with homologous recombination repair gene alterations. British Journal of Cancer, 129(3), 475-485. [More Information]
Agar, M., Nowak, A., Hovey, E., Barnes, E., Simes, R., Vardy, J., Wheeler, H., Kong, B., Leonard, R., Hall, M., Tim, E., Spyridopoulos, D., Sim, H., et al (2023). Acetazolamide versus placebo for cerebral oedema requiring dexamethasone in recurrent and/or progressive high-grade glioma: phase II randomised placebo-controlled double-blind study. BMJ Supportive and Palliative Care, 13(3), 354-362. [More Information]
Brown, B., Galpin, K., Simes, R., Boyer, M., Chin, V., Young, J. (2023). Clinicians' Evaluation of Lung Cancer Clinical Quality Indicators and Comparative Performance Data in Practice. European Journal of Cancer Care, 2023, 6636704. [More Information]
Zhang, J., Kong, W., Hu, P., Jonker, D., Moore, M., Ringash, J., Shapiro, J., Zalcberg, J., Simes, R., Tu, D., et al (2023). Clustering on longitudinal quality-of-life measurements using growth mixture models for clinical prognosis: Implementation on CCTG/AGITG CO.20 trial. Cancer Medicine, 12(5), 6117-6128. [More Information]
Kansara, M., Bhardwaj, N., Thavaneswaran, S., Xu, C., Lee, J., Chang, L., Madison, R., Lin, F., Hsu, E., Patel, V., Simes, R., et al (2023). Early circulating tumor DNA dynamics as a pan-tumor biomarker for long-term clinical outcome in patients treated with durvalumab and tremelimumab. Molecular Oncology, 17(2), 298-311. [More Information]
Tang, M., Pearson, S., Simes, R., Chua, B. (2023). Harnessing Real-World Evidence to Advance Cancer Research. Current Oncology, 30(2), 1844-1859. [More Information]
Lam, L., Pavlakis, N., Shitara, K., Sjoquist, K., Martin, A., Yip, S., Kang, Y., Bang, Y., Chen, L., Moehler, M., Hague, W., Gebski, V., Jaworski, A., Simes, R., et al (2023). INTEGRATE II: randomised phase III controlled trials of regorafenib containing regimens versus standard of care in refractory Advanced Gastro-Oesophageal Cancer (AGOC): a study by the Australasian Gastro-Intestinal Trials Group (AGITG). BMC Cancer, 23(1). [More Information]
Zeverijn, L., Looze, E., Thavaneswaran, S., van Berge Henegouwen, J., Simes, R., Hoes, L., Sjoquist, K., van der Wijngaart, H., Sebastian, L., Geurts, B., Lee, C., Espinoza, D., Lin, F., et al (2023). Limited clinical activity of palbociclib and ribociclib monotherapy in advanced cancers with cyclin D-CDK4/6 pathway alterations in the Dutch DRUP and Australian MoST trials. International Journal of Cancer, 153(7), 1413-1422. [More Information]
M. Naeini, M., Newell, F., Aoude, L., Bonazzi, V., Patel, K., Lampe, G., Koufariotis, L., Lakis, V., Addala, V., Kondrashova, O., Wilson, K., Barnes, E., Simes, R., Gebski, V., et al (2023). Multi-omic features of oesophageal adenocarcinoma in patients treated with preoperative neoadjuvant therapy. Nature Communications, 14(1), 3155. [More Information]
Sim, H., Wachsmuth, L., Barnes, E., Yip, S., Koh, E., Hall, M., Jennens, R., Kong, B., Simes, R., Khasraw, M., et al (2023). NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma. Neuro-Oncology Advances, 5(1), vdad124. [More Information]
Day, D., Toh, H., Ali, R., Foo, E., Simes, R., Chia, J., Segelov, E. (2023). Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial. JCO Global Oncology, 9, e2300040. [More Information]
Mercieca-Bebber, R., Eggins, R., Brown, K., Gebski, V., Brewer, K., Lai, L., Bailey, L., Solomon, M., Lumley, J., Hewett, P., Wilson, K., Hague, W., Simes, R., Stevenson, A., et al (2023). Patient-Reported Bowel, Urinary, and Sexual Outcomes After Laparoscopic-Assisted Resection or Open Resection for Rectal Cancer: The Australasian Laparoscopic Cancer of the Rectum Randomized Clinical Trial (ALaCart). Annals of Surgery, 277(3), 449-455. [More Information]
Zhou, J., Wu, R., Williams, C., Emberson, J., Reith, C., Keech, A., Robson, J., Armitage, J., Gray, A., Simes, R., et al (2023). Prediction Models for Individual-Level Healthcare Costs Associated with Cardiovascular Events in the UK. PharmacoEconomics, 41(5), 547-559. [More Information]
Seidler, A., Willson, M., Aberoumand, M., Williams, J., Hunter, K., Barba, A., Simes, R., Webster, A. (2023). The changing landscape of clinical trials in Australia. Medical Journal of Australia, 219(5), 192-196. [More Information]
Tarnow-Mordi, W., Robledo, K., Marschner, I., Seidler, A., Simes, R. (2023). To guide future practice, perinatal trials should be much larger, simpler and less fragile with close to 100% ascertainment of mortality and other key outcomes. Seminars in Perinatology, 47(5), 151789. [More Information]
Sjoquist, K., Martin, A., Pavlakis, N., Goldstein, D., Tsobanis, E., Moses, D., Maher, R., Hague, W., Gebski, V., Stockler, M., Simes, R. (2023). Value of central review of RECIST v1.1 outcomes in the AGITG INTEGRATE randomised phase 2 international trial for advanced oesophago-gastric cancer. Journal of Cancer Research and Clinical Oncology, 149, 4959-4965. [More Information]
Morton, R., Tuffaha, H., Novakova, V., Spencer, J., Hawley, C., Peyton, P., Higgins, A., Marsh, J., Taylor, W., Huckson, S., Simes, R., et al (2022). Approaches to prioritising research for clinical trial networks: a scoping review. Trials, 23(1). [More Information]
Law, C., Stevenson, A., Solomon, M., Hague, W., Simes, R., Morton, R. (2022). ASO Author Reflections: Is laparoscopic-Assisted Surgery More Costly than Traditional Open Resection for Rectal Cancer Treatment? Annals of Surgical Oncology, 29(3), 1935-1936. [More Information]
Nicholls, D., Xu, M., Kaneswaran, L., Grant, B., Brown, M., Shapiro, J., Karapetis, C., Simes, R., Jonker, D., Tu, D., et al (2022). Assessment of Successful Randomization Through a Machine Learning and Visualization Tool for Pre-treatment Symptoms: Examples from CCTG/AGITG CO.17 and CO.20 Trials. Revue d'Intelligence Artificielle, 36(6), 913-918. [More Information]
Stewart, R., Kirby, A., White, H., Marschner, S., West, M., Thompson, P., Sullivan, D., Janus, E., Hunt, D., Kritharides, L., Keech, A., Simes, R., et al (2022). B-Type Natriuretic Peptide and Long-Term Cardiovascular Mortality in Patients With Coronary Heart Disease. Journal of the American Heart Association, 11(13). [More Information]
Coskinas, X., Simes, R., Martin, A. (2022). Changes to design and analysis elements of research plans during randomised controlled trials in Australia. Medical Journal of Australia, 217(10), 526-531. [More Information]
West, M., Kirby, A., Stewart, R., Blankenberg, S., Sullivan, D., White, H., Hunt, D., Marschner, I., Janus, E., Kritharides, L., Simes, R., et al (2022). Circulating Cystatin C Is an Independent Risk Marker for Cardiovascular Outcomes, Development of Renal Impairment, and Long-Term Mortality in Patients With Stable Coronary Heart Disease: The LIPID Study. Journal of the American Heart Association, 11(5), e020745. [More Information]
Thompson, P., Hui, J., Beilby, J., Palmer, L., Watts, G., West, M., Kirby, A., Marschner, S., Simes, R., Sullivan, D., et al (2022). Common genetic variants do not predict recurrent events in coronary heart disease patients. BMC Cardiovascular Disorders, 22(1), 96-1-96-9. [More Information]
Singh, K., Batich, K., Wen, P., Tan, A., Bagley, S., Lim, M., Platten, M., Colman, H., Ashley, D., Chang, S., Simes, R., et al (2022). Designing Clinical Trials for Combination Immunotherapy: A Framework for Glioblastoma. Clinical Cancer Research, 28(4), 585-593. [More Information]
Robledo, K., Tarnow-Mordi, W., Rieger, I., Suresh, P., Martin, A., Yeung, C., Ghadge, A., Liley, H., Osborn, D., Morris, J., Hague, W., Kluckow, M., Keech, A., Kirby, A., Simes, R., et al (2022). Effects of delayed versus immediate umbilical cord clamping in reducing death or major disability at 2 years corrected age among very preterm infants (APTS): a multicentre, randomised clinical trial. The Lancet Child and Adolescent Health, 6(3), 150-157. [More Information]
Cho, D., Cheyne, S., Lord, S., Simes, R., Lee, C. (2022). Extrapolating evidence for molecularly targeted therapies from common to rare cancers: a scoping review of methodological guidance. BMJ Open, 12(7). [More Information]
Keane, C., O'Grady, G., Bissett, I., Hayes, J., Hulme-Moir, M., Eglinton, T., Solomon, M., Lumley, J., Simes, R., Stevenson, A. (2022). Functional Outcome of Laparoscopic-Assisted Resection Versus Open Resection of Rectal Cancer: A Secondary Analysis of the Australasian Laparoscopic Cancer of the Rectum Trial. Diseases of the Colon and Rectum, 65(7), E698-E706. [More Information]
Tang, M., Lee, C., Lewis, C., Boyer, M., Brown, B., Schaffer, A., Pearson, S., Simes, R. (2022). Generalizability of immune checkpoint inhibitor trials to real-world patients with advanced non-small cell lung cancer. Lung Cancer, 166, 40-48. [More Information]
Law, C., Stevenson, A., Solomon, M., Hague, W., Wilson, K., Simes, R., Morton, R. (2022). Healthcare Costs of Laparoscopic versus Open Surgery for Rectal Cancer Patients in the First 12 Months: A Secondary Endpoint Analysis of the Australasian Laparoscopic Cancer of the Rectum Trial (ALaCaRT). Annals of Surgical Oncology, 29(3), 1923-1934. [More Information]
Kong, B., Sim, H., Barnes, E., Nowak, A., Hovey, E., Jeffree, R., Harrup, R., Parkinson, J., Gan, H., Pinkham, M., Yip, S., Hall, M., Tu, E., Carter, C., Simes, R., et al (2022). Multi-Arm GlioblastoMa Australasia (MAGMA): Protocol for a multiarm randomised clinical trial for people affected by glioblastoma. BMJ Open, 12(9). [More Information]
Cho, D., Lord, S., Simes, R., Cooper, W., Friedlander, M., Bae, S., Lee, C. (2022). Next-generation sequencing, should I use anti-HER2 therapy for HER2-amplified tumors off-label? Illustrating an extrapolation framework. Therapeutic Advances in Medical Oncology, 14. [More Information]
Mercieca-Bebber, R., Barnes, E., Wilson, K., Samoon, Z., Walpole, E., Mai, T., Ackland, S., Burge, M., Dickie, G., Watson, D., Wang, T., Simes, R., Gebski, V., et al (2022). Patient-reported outcome (PRO) results from the AGITG DOCTOR trial: a randomised phase 2 trial of tailored neoadjuvant therapy for resectable oesophageal adenocarcinoma. BMC Cancer, 22(1), 276-1-276-11. [More Information]
Greenham, L., Bennett, P., Dansie, K., Mister, R., Smyth, B., Westall, P., Herzog, S., Brown, C., Simes, R., Morton, R., et al (2022). The Symptom Monitoring with Feedback Trial (SWIFT): protocol for a registry-based cluster randomised controlled trial in haemodialysis. Trials, 23(1), 419. [More Information]
Woodford, R., Zhou, D., Kok, P., Lord, S., Friedlander, M., Marschner, I., Simes, R., Lee, C. (2022). The validity of progression-free survival 2 as a surrogate trial end point for overall survival. Cancer, 128(7), 1449-1457. [More Information]
Chionh, F., Gebski, V., Al-Obaidi, S., Mooi, J., Bruhn, M., Lee, C., Chüeh, A., Williams, D., Weickhardt, A., Wilson, K., Simes, R., et al (2022). VEGF-A, VEGFR1 and VEGFR2 single nucleotide polymorphisms and outcomes from the AGITG MAX trial of capecitabine, bevacizumab and mitomycin C in metastatic colorectal cancer. Scientific Reports, 12(1), 1238-1-1238-14. [More Information]
Sim, H., McDonald, K., Lwin, Z., Barnes, E., Rosenthal, M., Foote, M., Koh, E., Back, M., Wheeler, H., Sulman, E., Buckland, M., Fisher, L., Leonard, R., Hall, M., Yip, S., Simes, R., Khasraw, M., et al (2021). A randomized phase II trial of veliparib, radiotherapy, and temozolomide in patients with unmethylated MGMT glioblastoma: The VERTU study. Neuro-Oncology, 23(10), 1736-1749. [More Information]
Oar, A., Lee, M., Le, H., Wilson, K., Aiken, C., Chantrill, L., Simes, R., Nguyen, N., Barbour, A., Samra, J., Sjoquist, K., Espinoza, D., Gebski, V., Yip, S., Kneebone, A., Goldstein, D., et al (2021). AGITG MASTERPLAN: a randomised phase II study of modified FOLFIRINOX alone or in combination with stereotactic body radiotherapy for patients with high-risk and locally advanced pancreatic cancer. BMC Cancer, 21(1), 936. [More Information]
Tang, M., Pearson, S., Schaffer, A., Lewis, C., John, T., Simes, R., Lee, C. (2021). Are clinical trial eligibility criteria representative of older patients with lung cancer? A population-based data linkage study. Journal of Geriatric Oncology, 12(6), 930-936. [More Information]
Tang, M., Schaffer, A., Kiely, B., Daniels, B., Lee, C., Simes, R., Pearson, S. (2021). Cardiac assessment in Australian patients receiving (neo)adjuvant trastuzumab for HER2-positive early breast cancer: a population-based study. Breast Cancer Research and Treatment, 187(3), 893-902. [More Information]
Petit, C., Lacas, B., Pignon, J., Le, Q., Gregoire, V., Grau, C., Hackshaw, A., Zackrisson, B., Parmar, M., Lee, J., et al (2021). Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis. The Lancet Oncology, 22(5), 727-736. [More Information]
Lin, F., Thavaneswaran, S., Grady, J., Ballinger, M., Oakes, S., Desai, J., Lee, C., Simes, R., Thomas, D. (2021). Criteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology. n p j Precision Oncology, 5(1), 58. [More Information]
Tan, A., Askie, L., Hunter, K., Barba, A., Simes, R., Seidler, A. (2021). Data sharing—trialists' plans at registration, attitudes, barriers and facilitators: A cohort study and cross-sectional survey. Research Synthesis Methods, 12(5), 641-657. [More Information]
Orkin, A., Gill, P., Ghersi, D., Campbell, L., Sugarman, J., Emsley, R., Steg, P., Weijer, C., Simes, R., Rombey, T., et al (2021). Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement. JAMA - Journal of the American Medical Association, 326(3), 257-265. [More Information]
Briffa, T., Symons, T., Zeps, N., Straiton, N., Tarnow-Mordi, W., Simes, R., Harris, I., Cruz, M., Webb, S., Litton, E., et al (2021). Normalising comparative effectiveness trials as clinical practice. Trials, 22(1), 620. [More Information]
Field, K., Barnes, E., Sim, H., Nowak, A., Simes, R., Rosenthal, M., Wheeler, H., Hovey, E., Cher, L. (2021). Outcomes from the use of computerized neurocognitive testing in a recurrent glioblastoma clinical trial. Journal of Clinical Neuroscience, 94, 321-327. [More Information]
Coskinas, X., Schou, M., Simes, R., Martin, A. (2021). Reacting to prognostic covariate imbalance in randomised controlled trials. Contemporary Clinical Trials, 110, 106544-1-106544-7. [More Information]
Januszewski, A., Chen, D., Scott, R., O'Connell, R., Aryal, N., Sullivan, D., Watts, G., Taskinen, M., Barter, P., Best, J., Simes, R., Keech, A., Jenkins, A. (2021). Relationship of low molecular weight fluorophore levels with clinical factors and fenofibrate effects in adults with type 2 diabetes. Scientific Reports, 11(1), 18708. [More Information]
Law, C., Brewer, K., Brown, C., Wilson, K., Bailey, L., Hague, W., Simes, R., Stevenson, A., Solomon, M., Morton, R. (2021). Return to work following laparoscopic-assisted resection or open resection for rectal cancer: Findings from AlaCaRT—Australasian Laparoscopic Cancer of the Rectum Trial. Cancer Medicine, 10(2), 552-562. [More Information]
Tan, A., Bagley, S., Wen, P., Lim, M., Platten, M., Colman, H., Ashley, D., Wick, W., Chang, S., Galanis, E., Simes, R., et al (2021). Systematic review of combinations of targeted or immunotherapy in advanced solid tumors. Journal for ImmunoTherapy of Cancer, 9(7), e002459. [More Information]
Coskinas, X., Simes, R., Schou, M., Martin, A. (2020). Changes to aspects of ongoing randomised controlled trials with fixed designs. Trials, 21(1), 457. [More Information]
Tang, M., Schaffer, A., Kiely, B., Daniels, B., Simes, R., Lee, C., Pearson, S. (2020). Correction: Treatment patterns and survival in HER2-positive early breast cancer: a whole-of-population Australian cohort study (2007-2016). British Journal of Cancer, 123(5), 868. [More Information]
Hilvo, M., Meikle, P., Pedersen, E., Tell, G., Dhar, I., Brenner, H., Schottker, B., Laaperi, M., Kauhanen, D., Koistinen, K., Sullivan, D., Simes, R., et al (2020). Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients. European Heart Journal, 41(3), 371-380. [More Information]
Cipriani, A., Ioannidis, J., Rothwell, T., Glasziou, P., Li, T., Hernandez, A., Tomlinson, A., Simes, R., Naci, H. (2020). Generating comparative evidence on new drugs and devices after approval. The Lancet, 395(10228), 998-1010. [More Information]
Grimison, P., Mersiades, T., Kirby, A., Lintzeris, N., Morton, R., Haber, P., Olver, I., Walsh, A., McGregor, I., Cheung, Y., Simes, R., Stockler, M., et al (2020). Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial. Annals of Oncology, 31(11), 1553-1560. [More Information]
Barbour, A., Walpole, E., Mai, G., Barnes, E., Watson, D., Acland, S., Martin, J., Burge, M., Finch, R., Karapetis, C., Falk, G., Gebski, V., Oostendorp, M., Wilson, K., Simes, R., et al (2020). Preoperative cisplatin, fluorouracil, and docetaxel with or without radiotherapy after poor early response to cisplatin and fluorouracil for resectable oesophageal adenocarcinoma (AGITG DOCTOR): results from a multicentre, randomised controlled phase II trial. Annals of Oncology, 31(2), 236-245. [More Information]
Fulcher, J., Keech, A., Simes, R., Baigent, C., Collins, R. (2020). Questioning statin therapy for older patients – Authors' reply. The Lancet, 395(10240), 1832-1833. [More Information]
Seidler, A., Duley, L., Katheria, A., De Paco Matallana, C., Dempsey, E., Rabe, H., Kattwinkel, J., Mercer, J., Josephsen, J., Fairchild, K., Tarnow-Mordi, W., Kluckow, M., Hunter, K., Barba, A., Simes, R., Askie, L., et al (2020). Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): Study protocol. BMJ Open, 10(3), e034595. [More Information]
Tarnow-Mordi, W., Abdel-Latif, M., Martin, A., Pammi, M., Robledo, K., Manzoni, P., Osborn, D., Lui, K., Keech, A., Hague, W., Ghadge, A., Brown, R., Isaacs, D., Gordon, A., Askie, L., Deshpande, G., Tracy, M., Sinn, J., Simes, R., et al (2020). The effect of lactoferrin supplementation on death or major morbidity in very low birthweight infants (LIFT): a multicentre, double-blind, randomised controlled trial. The Lancet Child and Adolescent Health, 4(6), 444-454. [More Information]
Cao, J., Waldman, B., O'Connell, R., Sullivan, D., Scott, R., Aryal, N., Gebski, V., Marschner, I., Taskinen, M., Simes, R., McGill, N., Jenkins, A., Keech, A. (2020). Uric acid predicts long-term cardiovascular risk in type 2 diabetes but does not mediate the benefits of fenofibrate: The FIELD study. Diabetes, Obesity and Metabolism, 22(8), 1388-1396. [More Information]
Kok, P., Cho, D., Yoon, W., Ritchie, G., Marschner, I., Lord, S., Friedlander, M., Simes, R., Lee, C. (2020). Validation of Progression-Free Survival Rate at 6 Months and Objective Response for Estimating Overall Survival in Immune Checkpoint Inhibitor Trials: A Systematic Review and Meta-analysis. JAMA Network Open, 3(9), e2011809. [More Information]
Simes, R., Martin, A. (2019). Assumptions, damn assumptions and statistics. Annals of Oncology, 30(9), 1415-1416. [More Information]
Tang, M., Joensuu, H., Simes, R., Price, T., Yip, S., Hague, W., Sjoquist, K., Zalcberg, J. (2019). Challenges of international oncology trial collaboration-a call to action. British Journal of Cancer, 121(7), 515-521. [More Information]
Jayawardana, K., Mundra, P., Giles, C., Barlow, C., Nestel, P., Barnes, E., Kirby, A., Thompson, P., Sullivan, D., Alshehry, Z., Marschner, I., Simes, R., et al (2019). Changes in plasma lipids predict pravastatin efficacy in secondary prevention. JCI Insight, 4(13), 1-13. [More Information]
Stevenson, A., Solomon, M., Brown, C., Lumley, J., Hewett, P., Clouston, A., Gebski, V., Wilson, K., Hague, W., Simes, R. (2019). Disease-free Survival and Local Recurrence After Laparoscopic-assisted Resection or Open Resection for Rectal Cancer: The Australasian Laparoscopic Cancer of the Rectum Randomized Clinical Trial. Annals of Surgery, 269(4), 596-602. [More Information]
Ackland, S., Gebski, V., Zdenkowski, N., Wilson, A., Green, M., Tees, S., Dhillon, H., van Hazel, G., Levi, J., Simes, R., Coates, A., et al (2019). Dose intensity in anthracycline-based chemotherapy for metastatic breast cancer: mature results of the randomised clinical trial ANZ 9311. Breast Cancer Research and Treatment, 176(2), 357-365. [More Information]
Tang, M., Chen, J., Goldstein, D., Links, M., Lord, S., Marschner, I., Simes, R., Lee, C. (2019). Evaluation of Phase II Trial Design in Advanced Pancreatic Cancer. Pancreas, 48(10), 1274-1284. [More Information]
Wells, J., Tu, D., Siu, L., Shapiro, J., Jonker, D., Karapetis, C., Simes, R., Liu, G., Price, T., Tebbutt, N., et al (2019). Outcomes of Older Patients (> 70 Years) Treated With Targeted Therapy in Metastatic Chemorefractory Colorectal Cancer: Retrospective Analysis of NCIC CTG CO17 and CO20. Clinical Colorectal Cancer, 18(1), e140-e149. [More Information]
Tan, A., Jiang, I., Askie, L., Hunter, K., Simes, R., Seidler, A. (2019). Prevalence of trial registration varies by study characteristics and risk of bias. Journal of Clinical Epidemiology, 113, 64-74. [More Information]
Simes, J., Kirby, A., Tonkin, A. (2019). Response by Simes et al to Letter Regarding Article, "D-Dimer Predicts Long-Term Cause-Specific Mortality, Cardiovascular Events, and Cancer in Patients With Stable Coronary Heart Disease". Circulation, 139(9), 1245-1246. [More Information]
Dauzier, E., Lacas, B., Blanchard, P., Le, Q., Simon, C., Wolf, G., Janot, F., Horiuchi, M., Tobias, J., Moon, J., Simes, R., et al (2019). Role of chemotherapy in 5000 patients with head and neck cancer treated by curative surgery: A subgroup analysis of the meta-analysis of chemotherapy in head and neck cancer. Oral Oncology, 95, 106-114. [More Information]
Lassman, A., van den Bent, M., Gan, H., Reardon, D., Kumthekar, P., Butowski, N., Lwin, Z., Mikkelsen, T., Nabors, L., Papadopoulos, K., Simes, J., et al (2019). Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro-Oncology, 21(1), 106-114. [More Information]
Tang, M., Schaffer, A., Kiely, B., Daniels, B., Simes, R., Lee, C., Pearson, S. (2019). Treatment patterns and survival in HER2-positive early breast cancer: a whole-of-population Australian cohort study (2007-2016). British Journal of Cancer, 121(11), 904-911. [More Information]
Olafson, L., Siddell, A., Field, K., Byrnes, M., Rapkins, R., Ng, B., Nixdorf, S., Barnes, E., Johns, T., Yip, S., Simes, R., et al (2019). Whole genome and biomarker analysis of patients with recurrent glioblastoma on bevacizumab: A subset analysis of the CABARET trial. Journal of Clinical Neuroscience, 70, 157-163. [More Information]
Ameratunga, M., Pavlakis, N., Wheeler, H., Grant, R., Simes, R., Khasraw, M. (2018). Anti-angiogenic therapy for high-grade glioma. Cochrane Database of Systematic Reviews, 2018 (11), 1-52. [More Information]
Askie, L., Darlow, B., Finer, N., Schmidt, B., Stenson, B., Tarnow-Mordi, W., Davis, P., Carlo, W., Brocklehurst, P., Davies, L., Gebski, V., Hunter, K., Simes, R., et al (2018). Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA, 319(21), 2190-2201. [More Information]
Willeit, P., Ridker, P., Nestel, P., Simes, R., Tonkin, A., Pedersen, T., Schwartz, G., Olsson, A., Colhoun, H., Kronenberg, F., et al (2018). Baseline and on-statin treatment lipoprotein(a) levels for prediction of cardiovascular events: individual patient-data meta-analysis of statin outcome trials. The Lancet, 392(10155), 1311-1320. [More Information]
Thavaneswaran, S., Sebastian, L., Ballinger, M., Best, M., Hess, D., Lee, C., Sjoquist, K., Hague, W., Butow, P., Simes, R., et al (2018). Cancer Molecular Screening and Therapeutics (MoST): a framework for multiple, parallel signal-seeking studies of targeted therapies for rare and neglected cancers. Medical Journal of Australia, 209(8), 354.e1-354.e6. [More Information]
Rankin, N., Lai, M., Miller, D., Beale, P., Spigelman, A., Prest, G., Turley, K., Simes, R. (2018). Cancer multidisciplinary team meetings in practice: Results from a multi-institutional quantitative survey and implications for policy change. Asia-Pacific Journal of Clinical Oncology, 14(1), 74-83. [More Information]
Shapiro, J., Thavaneswaran, S., Underhill, C., Robledo, K., Karapetis, C., Day, F., Nott, L., Jefford, M., Chantrill, L., Pavlakis, N., Khasraw, M., Simes, R., Gebski, V., et al (2018). Cetuximab Alone or With Irinotecan for Resistant KRAS-, NRAS-, BRAF- and PIK3CA-wild-type Metastatic Colorectal Cancer: The AGITG Randomized Phase II ICECREAM Study. Clinical Colorectal Cancer, 17(4), 313-319. [More Information]
Field, K., Fitt, G., Rosenthal, M., Simes, R., Nowak, A., Barnes, E., Sawkins, K., Goh, C., Moffat, B., Salinas, S., et al (2018). Comparison between site and central radiological assessments for patients with recurrent glioblastoma on a clinical trial. Asia-Pacific Journal of Clinical Oncology, 14(5), e359-e365. [More Information]
Simes, R., Robledo, K., White, H., Espinoza, D., Stewart, R., Sullivan, D., Zeller, T., Hague, W., Nestel, P., Glasziou, P., Keech, A., et al (2018). D-dimer Predicts Long-Term Cause-Specific Mortality, Cardiovascular Events and Cancer in Patients with Stable Coronary Heart Disease: LIPID Study. Circulation, 138(7), 712-723. [More Information]
Fogarty, M., Osborn, D., Askie, L., Seidler, A., Hunter, K., Lui, K., Simes, R., Tarnow-Mordi, W. (2018). Delayed Versus Early Umbilical Cord Clamping for Preterm Infants: A Systematic Review and Meta-Analysis. American Journal of Obstetrics and Gynecology, 218(1), 1-18. [More Information]
Tarnow-Mordi, W., Morris, J., Kirby, A., Robledo, K., Askie, L., Brown, R., Evans, N., Finlayson, S., Fogarty, M., Gebski, V., Ghadge, A., Hague, W., Isaacs, D., Jeffery, M., Keech, A., Kluckow, M., Popat, H., Sebastian, L., Liley, H., Osborn, D., Simes, R., et al (2018). Delayed Versus Immediate Cord Clamping in Preterm Infants. Obstetrical and Gynecological Survey, 73(5), 265-266. [More Information]
Lawrence, N., Roncolato, F., Martin, A., Simes, R., Stockler, M. (2018). Effect Sizes Hypothesized and Observed in Contemporary Phase III Trials of Targeted and Immunological Therapies for Advanced Cancer. JNCI Cancer Spectrum, 2(4). [More Information]
Martin, A., Gibbs, E., Sjoquist, K., Pavlakis, N., Simes, R., Price, T., Shannon, J., Gill, S., Jain, V., Liu, G., et al (2018). Health-related quality of life associated with regorafenib treatment in refractory advanced gastric adenocarcinoma. Gastric Cancer, 21(3), 473-480. [More Information]
Mundra, P., Barlow, C., Nestel, P., Barnes, E., Kirby, A., Thompson, P., Sullivan, D., Alshehry, Z., Mellett, N., Huynh, K., Simes, R., et al (2018). Large-scale plasma lipidomic profiling identifies lipids that predict cardiovascular events in secondary prevention. JCI Insight, 3(17), e121326. [More Information]
Jonker, D., Nott, L., Yoshino, T., Gill, S., Shapiro, J., Ohtsu, A., Zalcberg, J., Vickers, M., Wei, A., Gao, Y., Simes, R., et al (2018). Napabucasin versus placebo in refractory advanced colorectal cancer: a randomised phase 3 trial. The Lancet Gastroenterology & Hepatology, 3(4), 263-270. [More Information]
Mersiades, T., Tognela, A., Haber, P., Stockler, M., Lintzeris, N., Simes, R., McGregor, I., Olver, I., Allsop, D., Gedye, C., Kirby, A., Morton, R., Wong, N., Walsh, A., Grimison, P., et al (2018). Oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: a study protocol for a pilot and definitive randomised double-blind placebo-controlled trial (CannabisCINV). BMJ Open, 8(9), 1-8. [More Information]
Sjoquist, K., Renfro, L., Simes, R., Tebbutt, N., Clarke, S., Seymour, M., Adams, R., Maughan, T., Saltz, L., Goldberg, R., et al (2018). Personalizing Survival Predictions in Advanced Colorectal Cancer: The ARCAD Nomogram Project. Journal of the National Cancer Institute, 110(6), 638-648. [More Information]
Sjoquist, K., Lord, S., Friedlander, M., Simes, R., Marschner, I., Lee, C. (2018). Progression-free survival as a surrogate endpoint for overall survival in modern ovarian cancer trials: a meta-analysis. Therapeutic Advances in Medical Oncology, 10, 1-16. [More Information]
Stenson, B., Donoghoe, M., Brocklehurst, P., Davis, P., Juszczak, E., Marschner, I., Simes, R., Tarnow-Mordi, W. (2018). Pulse Oximeter Saturation Targeting and Oximeter Changes in the Benefits of Oxygen Saturation Targeting (BOOST)-II Australia and BOOST-II UK Oxygen Trials. The Journal of Pediatrics, 204, 301-304.e2. [More Information]
Herzog, S., Shanahan, M., Grimison, P., Tran, A., Wong, N., Lintzeris, N., Simes, R., Stockler, M., Morton, R. (2018). Systematic Review of the Costs and Benefits of Prescribed Cannabis-Based Medicines for the Management of Chronic Illness: Lessons from Multiple Sclerosis. PharmacoEconomics, 36(1), 67-78. [More Information]
Lee, C., Hudson, M., Simes, R., Ribi, K., Bernhard, J., Coates, A. (2018). When do patient reported quality of life indicators become prognostic in breast cancer? Health and Quality of Life Outcomes, 16(1), 13. [More Information]
Ong, K., O'Connell, R., Januszewski, A., Jenkins, A., Xu, A., Sullivan, D., Barter, P., Scott, R., Taskinen, M., Waldman, B., Simes, R., Rye, K., Keech, A., et al (2017). Baseline circulating FGF21 concentrations and increase after fenofibrate treatment predict more rapid glycemic progression in type 2 diabetes: Results from the FIELD study. Clinical Chemistry, 63(7), 1261-1270. [More Information]
Cho, D., Roncolato, F., Man, J., Simes, R., Lord, S., Links, M., Lee, C. (2017). Clinical equipoise fortrials ofnovel biologic therapies, therapeutic success rates, and predictors of success: A meta-analysis. JCO Precision Oncology, 2017 (1). [More Information]
Hovey, E., Field, K., Rosenthal, M., Barnes, E., Cher, L., Nowak, A., Wheeler, H., Sawkins, K., Livingstone (nee Ratcliffe), A., Phal, P., Simes, R., et al (2017). Continuing or ceasing bevacizumab beyond progression in recurrent glioblastoma: An exploratory randomized phase II trial. Neuro-Oncology Practice, 4(3), 171-181. [More Information]
Meikle, P., Barlow, C., Nestel, P., Barnes, E., Kirby, A., Thompson, P., Sullivan, D., Alshehry, Z., Mellett, N., Huynh, K., Simes, R., et al (2017). Decreases in plasma phosphatidylinositol species partially explain the reduction in cardiovascular events after pravastatin therapy in secondary prevention. Atherosclerosis, 263, e239. [More Information]
Tarnow-Mordi, W., Morris, J., Kirby, A., Robledo, K., Askie, L., Brown, R., Evans, N., Finlayson, S., Fogarty, M., Gebski, V., Ghadge, A., Hague, W., Isaacs, D., Jeffery, M., Keech, A., Kluckow, M., Popat, H., Sebastian, L., Liley, H., Osborn, D., Simes, R., et al (2017). Delayed versus Immediate Cord Clamping in Preterm Infants. New England Journal of Medicine, 377(25), 2445-2455. [More Information]
van den Bent, M., Gan, H., Lassman, A., Kumthekar, P., Merrell, R., Butowski, N., Lwin, Z., Mikkelsen, T., Nabors, L., Simes, R., et al (2017). Efficacy of depatuxizumab mafodotin (ABT-414) monotherapy in patients with EGFR-amplified, recurrent glioblastoma: results from a multi-center, international study. Cancer Chemotherapy and Pharmacology, 80(6), 1209-1217. [More Information]
Field, K., King, M., Simes, R., Espinoza, D., Barnes, E., Sawkins, K., Rosenthal, M., Cher, L., Hovey, E., Wheeler, H., et al (2017). Health-related quality of life outcomes from CABARET: a randomized phase 2 trial of carboplatin and bevacizumab in recurrent glioblastoma. Journal of Neuro-Oncology, 133, 623-631. [More Information]
Stewart, R., Colquhoun, D., Marschner, S., Kirby, A., Simes, R., Nestel, P., Glozier, N., O’Neil, A., Oldenburg, B., White, H., et al (2017). Persistent psychological distress and mortality in patients with stable coronary artery disease. Heart, 103(23), 1860-1866. [More Information]
Meikle, P., Mundra, P., Barlow, C., Nestel, P., Barnes, E., Kirby, A., Thompson, P., Sullivan, D., Alshehry, Z., Mellett, N., Simes, R., et al (2017). Plasma lipidomic profiles in two large independent cohorts improve upon conventional risk factors to predict cardiovascular events. Atherosclerosis, 263, e4-e5. [More Information]
Driscoll, A., Barnes, E., Blankenberg, S., Colquhoun, D., Hunt, D., Nestel, P., Stewart, R., West, M., White, H., Simes, R., et al (2017). Predictors of incident heart failure in patients after an acute coronary syndrome: The LIPID heart failure risk-prediction model. International Journal of Cardiology, 248, 361-368. [More Information]
Wetzig, N., Gill, P., Espinoza, D., Mister, R., Stockler, M., Gebski, V., Ung, O., Campbell, I., Simes, R. (2017). Sentinel-Lymph-Node-Based Management or Routine Axillary Clearance? Five-Year Outcomes of the RACS Sentinel Node Biopsy Versus Axillary Clearance (SNAC) 1 Trial: Assessment and Incidence of True Lymphedema. Annals of Surgical Oncology, 24(4), 1064-1070. [More Information]
Field, K., Phal, P., Fitt, G., Goh, C., Nowak, A., Rosenthal, M., Simes, R., Barnes, E., Sawkins, K., Cher, L., et al (2017). The role of early magnetic resonance imaging in predicting survival on bevacizumab for recurrent glioblastoma: Results from a prospective clinical trial (CABARET). Cancer, 123(18), 3576-3582. [More Information]
Leong, T., Smithers, B., Haustermans, K., Michael, M., Gebski, V., Miller, D., Zalcberg, J., Boussioutas, A., Findlay, M., O'Connell, R., Verghis, J., Simes, R., et al (2017). TOPGEAR: A Randomized, Phase III Trial of Perioperative ECF Chemotherapy with or Without Preoperative Chemoradiation for Resectable Gastric Cancer: Interim Results from an International, Intergroup Trial of the AGITG, TROG, EORTC and CCTG. Annals of Surgical Oncology, 24(8), 2252-2258. [More Information]
Liu, G., Tu, D., Lewis, M., Cheng, D., Sullivan, L., Chen, Z., Morgen, E., Simes, R., Price, T., Tebbutt, N., et al (2016). Fc-(gamma) receptor polymorphisms, cetuximab therapy, and survival in the NCIC CTG CO.17 trial of colorectal cancer. Clinical Cancer Research, 22(10), 2435-2444. [More Information]
Schofield, P., Stockler, M., Zannino, D., Tebbutt, N., Price, T., Simes, R., Wong, N., Pavlakis, N., Ransom, D., Moylan, E., Wilcken, N., et al (2016). Hope, optimism and survival in a randomised trial of chemotherapy for metastatic colorectal cancer. Supportive Care in Cancer, 24(1), 401-408. [More Information]
Collins, R., Reith, C., Emberson, J., Armitage, J., Baigent, C., Blackwell, L., Blumenthal, R., Danesh, J., Smith, G., DeMets, D., MacMahon, S., Neal, B., Rodgers, A., Simes, R., et al (2016). Interpretation of the evidence for the efficacy and safety of statin therapy. The Lancet, 388(10059), 2532-2561. [More Information]
Hague, W., Simes, R., Kirby, A., Keech, A., White, H., Hunt, D., Nestel, P., Colquhoun, D., Pater, H., Stewart, R., Sullivan, D., et al (2016). Long-Term Effectiveness and Safety of Pravastatin in Patients With Coronary Heart Disease: Sixteen Years of Follow-Up of the LIPID Study. Circulation, 133(19), 1851-1860. [More Information]
Tarnow-Mordi, W., Stenson, B., Kirby, A., Juszczak, E., Donoghoe, M., Deshpande, S., Morley, C., King, A., Doyle, L., Fleck, B., Hague, W., Gebski, V., Ghadge, A., Keech, A., Kluckow, M., Evans, N., Simes, R., et al (2016). Outcomes of two trials of oxygen-saturation targets in preterm infants. New England Journal of Medicine, 374(8), 749-760. [More Information]
Alshehry, Z., Mundra, P., Barlow, C., Mellett, N., Wong, G., McConville, M., Simes, R., Tonkin, A., Sullivan, D., Barnes, E., Neal, B., et al (2016). Plasma lipidomic profiles improve upon traditional risk factors for the prediction of cardiovascular events in Type 2 diabetes. Circulation, 134(21), 1637-1650. [More Information]
Pavlakis, N., Sjoquist, K., Martin, A., Tsobanis, E., Yip, S., Kang, Y., Bang, Y., Alcindor, T., O'Callaghan, C., Burnell, M., Wong, K., Simes, R., et al (2016). Regorafenib for the treatment of advanced gastric cancer (INTEGRATE): A multinational placebo-controlled phase II Trial. Journal of Clinical Oncology, 34(23), 2728-2735. [More Information]
Segelov, E., Thavaneswaran, S., Waring, P., Desai, J., Robledo, K., Gebski, V., Elez, E., Nott, L., Karapetis, C., Lunke, S., Pavlakis, N., Khasraw, M., Wilson, C., Simes, R., et al (2016). Response to Cetuximab With or Without Irinotecan in Patients With Refractory Metastatic Colorectal Cancer Harboring the KRAS G13D Mutation: Australasian Gastro-Intestinal Trials Group ICECREAM Study. Journal of Clinical Oncology, 34(19), 2258-2264. [More Information]
Lee, C., Davies, L., Gebski, V., Lord, S., Di Leo, A., Johnston, S., Geyer, C., Cameron, D., Press, M., Ellis, C., Marschner, I., Simes, R., et al (2016). Serum human epidermal growth factor 2 extracellular domain as a predictive biomarker for lapatinib treatment efficacy in patients with advanced breast cancer. Journal of Clinical Oncology, 34(9), 936-944. [More Information]
Lam, J., Lord, S., Hunter, K., Simes, R., Vu, T., Askie, L. (2015). Australian clinical trial activity and burden of disease: an analysis of registered trials in National Health Priority Areas. Medical Journal of Australia, 203(2), 97-102. [More Information]
Tonkin, A., Blankenberg, S., Kirby, A., Zeller, T., Colquhoun, D., Funke-Kaiser, A., Hague, W., Hunt, D., Keech, A., Nestel, P., Sullivan, D., Simes, R., et al (2015). Biomarkers in stable coronary heart disease, their modulation and cardiovascular risk: The LIPID biomarker study. International Journal of Cardiology, 201, 499-507. [More Information]
Price, T., Bruhn, M., Lee, C., Hardingham, J., Townsend, A., Robledo, K., Simes, R., Weickhardt, A., Wrin, J., Wilson, C., Gebski, V., et al (2015). Correlation of extended RAS and PIK3CA gene mutation status with outcomes from the phase III AGITG MAX STUDY involving capecitabine alone or in combination with bevacizumab plus or minus mitomycin C in advanced colorectal cancer. British Journal of Cancer, 112(6), 963-970. [More Information]
Stevenson, A., Solomon, M., Lumley, J., Hewett, P., Clouston, A., Gebski, V., Davies, L., Wilson, C., Hague, W., Simes, R. (2015). Effect of laparoscopic-assisted resection vs open resection on pathological outcomes in rectal cancer: The ALaCaRT randomized clinical trial. JAMA - Journal of the American Medical Association, 314(13), 1356-1363. [More Information]
Fulcher, J., O'Connell, R., Voysey, M., Emberson, J., Blackwell, L., Mihaylova, B., Simes, J., Collins, R., Kirby, A., Colhoun, H., Keech, A., et al (2015). Efficacy and safety of LDL-lowering therapy among men and women: Meta-analysis of individual data from 174 000 participants in 27 randomised trials. The Lancet, 385(9976), 1397-1405. [More Information]
Whittle, J., Lickliter, J., Gan, H., Scott, A., Simes, R., Solomon, B., MacDiarmid, J., Brahmbhatt, H., Rosenthal, M. (2015). First in human nanotechnology doxorubicin delivery system to target epidermal growth factor receptors in recurrent glioblastoma. Journal of Clinical Neuroscience, 22(12), 1889-1894. [More Information]
Elmadahm, A., Gill, P., Bochner, M., Gebski, V., Zannino, D., Wetzig, N., Campbell, I., Stockler, M., Ung, O., Simes, R., Uren, R. (2015). Identification of the sentinel lymph node in the SNAC-1 trial. ANZ Journal of Surgery, 85(1-2), 58-63. [More Information]
Chandrasegaram, M., Goldstein, D., Simes, R., Gebski, V., Kench, J., Gill, A., Samra, J., Merrett, N., Richardson, A., Barbour, A. (2015). Meta-analysis of radical resection rates and margin assessment in pancreatic cancer. British Journal of Surgery, 102(12), 1459-1472. [More Information]
Chantrill, L., Nagrial, A., Watson, C., Johns, A., Martyn-Smith, M., Simpson, S., Mead, S., Jones, M., Samra, J., Gill, A., Chin, V., Sebastian, L., Sjoquist, K., Yip, S., Pavlakis, N., Grimison, P., Simes, R., et al (2015). Precision Medicine for Advanced Pancreas Cancer: The Individualized Molecular Pancreatic Cancer Therapy (IMPaCT) Trial. Clinical Cancer Research, 21(9), 2029-2037. [More Information]
Field, K., Simes, J., Nowak, A., Cher, L., Wheeler, H., Hovey, E., Brown, C., Barnes, E., Sawkins, K., Livingstone (nee Ratcliffe), A., et al (2015). Randomized phase 2 study of carboplatin and bevacizumab in recurrent glioblastoma. Neuro-Oncology, 17(11), 1504-1513. [More Information]
Wetzig, N., Gill, P., Zannino, D., Stockler, M., Gebski, V., Ung, O., Campbell, I., Simes, R. (2015). Sentinel Lymph Node Based Management or Routine Axillary Clearance? Three-year Outcomes of the RACS Sentinel Node Biopsy Versus Axillary Clearance (SNAC) 1 Trial. Annals of Surgical Oncology, 22(1), 17-23. [More Information]
Ghersi, D., Willson, M., Chan, M., Simes, R., Donoghue, E., Wilcken, N. (2015). Taxane-containing regimens for metastatic breast cancer. Cochrane Database of Systematic Reviews, 6, 1-170. [More Information]
Leong, T., Smithers, B., Michael, M., Gebski, V., Boussioutas, A., Miller, D., Simes, R., Zalcberg, J., Haustermans, K., Lordick, F., et al (2015). TOPGEAR: A randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric cancer (an international, intergroup trial of the AGITG/TROG/EORTC/NCIC CTG). BMC Cancer, 15(1), 1-6. [More Information]
Weickhardt, A., Williams, D., Lee, C., Chionh, F., Simes, R., Murone, C., Byth Wilson, K., Parry, M., Asadi, K., Scott, A., et al (2015). Vascular endothelial growth factor D expression is a potential biomarker of bevacizumab benefit in colorectal cancer. British Journal of Cancer, 113(1), 37-45. [More Information]
Simes, R., Becattini, C., Agnelli, G., Eikelboom, J., Kirby, A., Mister, R., Prandoni, P., Brighton, T. (2014). Aspirin for the Prevention of Recurrent Venous Thromboembolism: The INSPIRE Collaboration. Circulation, 130(13), 1062-1071. [More Information]
White, H., Tonkin, A., Simes, R., Stewart, R., Robledo, K., Thompson, P., Colquhoun, D., West, M., Nestel, P., Sullivan, D., Keech, A., et al (2014). Association of Contemporary Sensitive Troponin I Levels at Baseline and Change at 1 Year With Long - Term Coronary Events Following Myocardial Infarction or Unstable Angina. Journal of the American College of Cardiology, 63(4), 345-354. [More Information]
Jonker, D., Karapetis, C., Harbison, C., Oâ€™Callaghan, C., Tu, D., Simes, R., Malone, D., Langer, C., Tebbutt, N., Price, T., et al (2014). Epiregulin gene expression as a biomarker of benefit from cetuximab in the treatment of advanced colorectal cancer. British Journal of Cancer, 110(3), 648-655. [More Information]
Ransom, D., Wilson, C., Fournier, M., Simes, R., Gebski, V., Yip, D., Tebbutt, N., Karapetis, C., Ferry, D., Gordon, S., et al (2014). Final results of Australasian Gastrointestinal Trials Group ARCTIC study: An audit of raltitrexed for patients with cardiac toxicity induced by fluoropyrimidines. Annals of Oncology, 25(1), 117-121. [More Information]
Mcgrath, P., Ghersi, D., Simes, R., Wilcken, N. (2014). Larger versus smaller dose of the same drug/s regimen for metastatic breast cancer. Cochrane Database of Systematic Reviews, 2014 (5). [More Information]
Funke-Kaiser, A., Robledo, K., Colquhoun, D., Zeller, T., Hunt, D., Simes, R., Sullivan, D., Sydow, K., West, M., White, H., et al (2014). Midregional proadrenomedullin and its change predicts recurrent major coronary events and heart failure in stable coronary heart disease patients: the LIPID study. International Journal of Cardiology, 172(2), 411-418. [More Information]
Chen, J., Hovey, E., Rosenthal, M., Livingstone (nee Ratcliffe), A., Simes, R. (2014). Neuro-oncology practices in Australia: A Cooperative Group for Neuro-Oncology patterns of care study. Asia-Pacific Journal of Clinical Oncology, 10(2), 162-167. [More Information]
Karapetis, C., Jonker, D., Daneshmand, M., Hanson, J., O'Callghan, C., Marginean, C., Zalcberg, J., Simes, R., Moore, M., Tebbutt, N., et al (2014). PIK3CA, BRAF, and PTEN Status and Benefit from Cetuximab in the Treatment of Advanced Colorectal Cancer--Results from NCIC CTG/AGITG CO.17. Clinical Cancer Research, 20(3), 744-753. [More Information]
White, H., Tonkin, A., Simes, R., Stewart, R., Robledo, K. (2014). Reply to Letter to the Editor: Troponin I to target treatments which reduce cardiovascular risk - while waiting for Godot. Journal of the American College of Cardiology, 636(25), 2876-2886.
Hudson, H., Lo, S., Simes, R., Tonkin, A., Heritier, S. (2014). Semiparametric methods for multistate survival models in randomised trials. Statistics in Medicine, 33, 1621-1645. [More Information]
Carter, H., Zannino, D., Simes, R., Schofield, D., Howard, K., Zalcberg, J., Price, T., Tebbutt, N. (2014). The cost effectiveness of bevacizumab when added to capecitabine, with or without mitomycin-C, in first line treatment of metastatic colorectal cancer: Results from the Australasian phase III MAX study. European Journal of Cancer, 50(3), 535-543. [More Information]
Sommeijer, D., Karapetis, C., Zalcberg, J., Tu, D., Jonker, D., Simes, R., Tebbutt, N., Yip, D., Price, T., Oâ€™CALLAGHAN, C. (2014). The relationship between rash, tumour KRAS mutation status and clinical and quality of life outcomes in patients with advanced colorectal cancer treated with cetuximab in the NCIC CTG/AGITG CO.17. Acta Oncologica, 53(7), 877-884. [More Information]
Boekholdt, S., Hovingh, G., Mora, S., Arsenault, B., Amarenco, P., Pedersen, T., LaRosa, J., Waters, D., DeMicco, D., Simes, R., Keech, A., et al (2014). Very low levels of atherogenic lipoproteins and the risk for cardiovascular events: a meta-analysis of statin trials. Journal of the American College of Cardiology, 64(5), 485-494. [More Information]
Glasziou, P., Irwig, L., Kirby, A., Tonkin, A., Simes, R. (2014). Which lipid measurement should we monitor? An analysis of the LIPID study. BMJ Open, 4(2), 1-6. [More Information]
Simes, R., Winship, I., McNeil, J. (2013). A funding model for public-good clinical trials. Medical Journal of Australia, 199(2), 90-91. [More Information]
Lee, C., Simes, R., Brown, C., Gebski, V., Pfisterer, J., Swart, A., Berton-Rigaud, D., Plante, M., Skeie-Jensen, T., Vergote, I., Lord, S., et al (2013). A prognostic nomogram to predict overall survival in patients with platinum-sensitive recurrent ovarian cancer. Annals of Oncology, 24(4), 937-943. [More Information]
Simes, R., Eikelboom, J., Brighton, T. (2013). Aspirin for preventing venous thromboembolism. New England Journal of Medicine, 368(8), 773. [More Information]
Vickers, M., Karapetis, C., Tu, D., O'Callaghan, C., Price, T., Tebbutt, N., van Hazel, G., Shapiro, J., Pavlakis, N., Gibbs, P., Simes, R., et al (2013). Association of hypomagnesemia with inferior survival in a phase III, randomized study of cetuximab plus best supportive care versus best supportive care alone: NCIC CTG/AGITG CO.17. Annals of Oncology, 24(4), 953-960. [More Information]
White, H., Simes, R., Stewart, R., Blankenberg, S., Barnes, E., Marschner, I., Thompson, P., West, M., Zeller, T., Colquhoun, D., Keech, A., Sullivan, D., et al (2013). Changes in lipoprotein-associated phospholipase A2 activity predict coronary events and partly account for the treatment effect of pravastatin: results from the Long-Term Intervention with Pravastatin in Ischemic Disease study. Journal of the American Heart Association, 2(5), 1-12. [More Information]
Stenson, B., Tarnow-Mordi, W., Darlow, B., Simes, R., Juszczak, E., Askie, L., Battin, M., Bowler, U., Broadbent, R., Cairns, P., Donoghoe, M., Ghadge, A., Hague, W., Kirby, A., et al (2013). Oxygen Saturation and Outcomes in Preterm Infants. New England Journal of Medicine, 368(22), 2094-2104. [More Information]
Siu, L., Shapiro, J., Jonker, D., Karapetis, C., Zalcberg, J., Simes, R., Couture, F., Moore, M., Price, T., Siddiqui, J., et al (2013). Phase III Randomized, Placebo-Controlled Study of Cetuximab Plus Brivanib Alaninate Versus Cetuximab Plus Placebo in PatientsWith Metastatic, Chemotherapy-Refractory, Wild-TypeK-RASColorectal Carcinoma: The NCIC Clinical Trials Group and AGITG CO.20 Trial. Journal of Clinical Oncology, 31(19), 2477-2484. [More Information]
Nestel, P., Barnes, E., Tonkin, A., Simes, R., Fournier, M., White, H., Colquhoun, D., Blankenberg, S., Sullivan, D. (2013). Plasma Lipoprotein(a) Concentration Predicts Future Coronary and Cardiovascular Events in Patients With Stable Coronary Heart Disease. Arteriosclerosis, Thrombosis, and Vascular Biology, 33(12), 2902-2908. [More Information]
Price, T., Hardingham, J., Lee, C., Townsend, A., Wrin, J., Wilson, K., Weickhardt, A., Simes, R., Murone, C., Tebbutt, N. (2013). Prognostic impact and the relevance of PTEN copy number alterations in patients with advanced colorectal cancer (CRC) receiving bevacizumab. Cancer Medicine, 2(3), 277-285. [More Information]
Martin, A., Simes, R. (2013). Quality-adjusted survival as an end point in breast cancer trials. Clinical Investigation, 3(6), 545-555. [More Information]
Anderson, C., Heeley, E., Huang, Y., Wang, J., Stapf, C., Delcourt, C., Lindley, R., Robinson, T., Lavados, P., Neal, B., Hata, J., Arima, H., Heritier, S., Li, Q., Woodward, M., Simes, R., Chalmers, J., et al (2013). Rapid Blood-Pressure Lowering in Patients with Acute Intracerebral Hemorrhage. New England Journal of Medicine, 368(25), 2355-2365. [More Information]
Tarnow-Mordi, W., Simes, R., Cruz, M. (2013). Strategies to accelerate recruitment to NHMRC multi-centre clinical trials. Journal of Paediatrics and Child Health, 49(1), e103-e105. [More Information]
Simes, R., Webb, S. (2013). Sustaining Australian research through clinical trials and investigator networks. Medical Journal of Australia, 198(3), 127-128. [More Information]
Lee, C., Gebski, V., Coates, A., Veillard, A., Harvey, V., Tattersall, M., Byrne, M., Brigham, B., Forbes, J., Simes, R. (2013). Trade-offs in quality of life and survival with chemotherapy for advanced breast cancer: mature results of a randomized trial comparing single-agent mitoxantrone with combination cyclophosphamide, methotrexate, 5-fluorouracil and prednisone. SpringerPlus, 2(391), 1-10. [More Information]
Boekholdt, S., Arsenault, B., Mora, S., Pedersen, T., LaRosa, J., Nestel, P., Simes, R., Durrington, P., Hitman, G., Welch, K., et al (2012). Association of LDL cholesterol, non-HDL cholesterol, and apolipoprotein B levels with risk of cardiovascular events among patients treated with statins: a meta-analysis. JAMA - Journal of the American Medical Association, 307(12), 1302-1309. [More Information]
Ting, R., Keech, A., Drury, P., Donoghoe, M., Hedley, J., Jenkins, A., Davis, T., Lehto, S., Celermajer, D., Simes, R., Rajamani, K., et al (2012). Benefits and Safety of Long-Term Fenofibrate Therapy in People With Type 2 Diabetes and Renal Impairment - The FIELD Study. Diabetes Care, 35(2), 218-225. [More Information]
Price, T., Zannino, D., Wilson, C., Simes, R., Cassidy, J., Van Hazel, G., Robinson, B., Broad, A., Ganju, V., Ackland, S., Tebbutt, N. (2012). Bevacizumab is equally effective and no more toxic in elderly patients with advanced colorectal cancer: a subgroup analysis from the AGITG MAX trial: an international randomised controlled trial of Capecitabine, Bevacizumab and Mitomycin C. Annals of Oncology, 23(6), 1531-1536. [More Information]
Carter, H., Lord, S., Martin, A., Gill, G., Lee, C., Howard, K., Wetzig, N., Simes, R. (2012). Effectiveness and cost-effectiveness of sentinel lymph node biopsy compared with axillary node dissection in patients with early-stage breast cancer: a decision model analysis. British Journal of Cancer, 106(6), 1045-1052. [More Information]
Tonkin, A., Hunt, D., Voysey, M., Kesaniemi, Y., Hamer, A., Waites, J., Mahar, L., Mann, S., Glasziou, P., Forder, P., Simes, R., Keech, A. (2012). Effects of fenofibrate on cardiovascular events in patients with diabetes, with and without prior cardiovascular disease: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. American Heart Journal, 163(3), 508-514. [More Information]
Dear, R., Barratt, A., Evans, A., Simes, R., Newsom, J., Kent, D., Crossing, S., Holliday, C., Segelov, E., Hruby, G., Tattersall, M. (2012). Identifying and prioritising gaps in colorectal cancer trials research in Australia. Medical Journal of Australia, 197(9), 507-511. [More Information]
Lee, C., Marschner, I., Simes, R., Voysey, M., Egleston, B., Hudes, G., de Souza, P. (2012). Increase in Cholesterol PredictsSsurvival Advantage in Renal Cell Carcinoma Patients Treated with Temsirolimus. Clinical Cancer Research, 18(11), 3188-3196. [More Information]
Emberson, J., Kearney, P., Blackwell, L., Newman, C., Reith, C., Bhala, N., Holland, L., Peto, R., Keech, A., Collins, R., Simes, R., et al (2012). Lack of effect of lowering LDL cholesterol on cancer: meta-analysis of individual data from 175 000 people in 27 randomised trials of statin therapy. PloS One, 7(1), 1-10. [More Information]
Staub, L., Dyer, S., Lord, S., Simes, R. (2012). Linking the evidence: intermediate outcomes in medical test assessments. International Journal of Technology Assessment in Health Care, 28(1), 52-58. [More Information]
Brighton, T., Eikelboom, J., Robledo, K., Mister, R., Gallus, A., Ockelford, P., Gibbs, H., Hague, W., Xavier, D., Diaz, R., Kirby, A., Simes, R. (2012). Low-Dose Aspirin for Preventing Recurrent Venous Thromboembolism. New England Journal of Medicine, 367(2), 1979-1987. [More Information]
Mihaylova, B., Emberson, J., Blackwell, L., Keech, A., Simes, R., Barnes, E., Voysey, M., Gray, A., Collins, R., Baigent, C., et al (2012). The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. The Lancet, 380(9841), 581-590. [More Information]
Keech, A., Simes, R., Fulcher, J. (2012). The role of statin therapy in patients with lower vascular risk. Medical Journal of Australia, 197(3), 130-131. [More Information]
Staub, L., Lord, S., Simes, R., Dyer, S., Houssami, N., Chen, R., Irwig, L. (2012). Using patient management as a surrogate for patient health outcomes in diagnostic test evaluation. BMC Medical Research Methodology, 12, 1-12. [More Information]
Lee, C., Hudson, M., Stockler, M., Coates, A., Ackland, S., Gebski, V., Lord, S., Friedlander, M., Boyle, F., Simes, R. (2011). A nomogram to predict survival time in women starting first-line chemotherapy for advanced breast cancer. Breast Cancer Research and Treatment, 129(2), 467-476. [More Information]
Sullivan, D., Forder, P., Simes, R., Whiting, M., Kritharides, L., Merrifield, A., Donoghoe, M., Colman, P., Neil, G., Haapamaki, H., Keech, A. (2011). Associations between the use of metformin, sulphonylureas, or diet alone and cardiovascular outcomes in 6005 patients with type 2 diabetes in the FIELD study. Diabetes Research and Clinical Practice, 94(2), 284-290. [More Information]
Stockler, M., Harvey, V., Francis, P., Byrne, M., Ackland, S., Fitzharris, B., Van Hazel, G., Wilcken, N., Grimison, P., Nowak, A., Zannino, D., Gebski, V., Coates, A., et al (2011). Capecitabine Versus Classical Cyclophosphamide, Methotrexate, and Fluorouracil As First-Line Chemotherapy for Advanced Breast Cancer. Journal of Clinical Oncology, 29(34), 4498-4504. [More Information]
Lee, C., Gurney, H., Brown, C., Sorio, R., Donadello, N., Tulunay, G., Meier, W., Bacon, M., Maenpaa, J., Petru, E., Gebski, V., Lord, S., Simes, R., et al (2011). Carboplatin-paclitaxel-induced leukopenia and neuropathy predict progression-free survival in recurrent ovarian cancer. British Journal of Cancer, 105(3), 360-365. [More Information]
Lee, C., Friedlander, M., Brown, C., Gebski, V., Georgoulopoulos, A., Vergote, I., Pignata, S., Donadello, N., Schmalfeldt, B., Delva, R., Lord, S., Simes, R., et al (2011). Early Decline in Cancer Antigen 125 as a Surrogate for Progression-Free Survival in Recurrent Ovarian Cancer. Journal of the National Cancer Institute, 103(17), 1338-1342. [More Information]
Davis, T., Ting, R., Best, J., Donoghoe, M., Drury, P., Sullivan, D., Jenkins, A., O'Connell, R., Whiting, M., Glasziou, P., Simes, R., Gebski, V., Keech, A., et al (2011). Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia, 54(2), 280-290. [More Information]
Goel, S., Simes, R., Beith, J. (2011). Exploratory analysis of cardiac biomarkers in women with normal cardiac function receiving trastuzumab for breast cancer. Asia-Pacific Journal of Clinical Oncology, 7(3), 276-280. [More Information]
de Boer, S., Barnes, E., Westerhout, C., Simes, J., Granger, C., Kastrati, A., Widimsky, P., de Boer, M., Zijlstra, F., Boersma, E. (2011). High-risk patients with ST-elevation myocardial infarction derive greatest absolute benefit from primary percutaneous coronary intervention: Results from the Primary Coronary Angioplasty Trialist versus Thrombolysis (PCAT)-2 Collaboration. American Heart Journal, 161(3), 500-507.e1. [More Information]
Dear, R., Barratt, A., McGeechan, K., Askie, L., Simes, R., Tattersall, M. (2011). Landscape of cancer clinical trials in Australia: using trial registries to guide future research. Medical Journal of Australia, 194(8), 387-391. [More Information]
Simes, R. (2011). Medical Oncology Group of Australia Cancer Achievement Award - Inspirations and influences for a life in clinical trials. Cancer Forum, 35(1), 48-50.
Ananda, S., Nowak, A., Cher, L., Dowling, A., Brown, C., Simes, R., Rosenthal, M. (2011). Phase 2 trial of temozolomide and pegylated liposomal doxorubicin in the treatment of patients with glioblastoma multiforme following concurrent radiotherapy and chemotherapy. Journal of Clinical Neuroscience, 18(11), 1444-1448. [More Information]
Lee, C., Simes, R., Brown, C., Lord, S., Wagner, U., Plante, M., Vergote, I., Pisano, C., Parma, G., Burges, A., Gebski, V., et al (2011). Prognostic nomogram to predict progression-free survival in patients with platinum-sensitive recurrent ovarian cancer. British Journal of Cancer, 105(8), 1144-1150. [More Information]
Cox, K., Goel, S., O'Connell, R., Boyer, M., Beale, P., Simes, R., Stockler, M. (2011). Randomized cross-over trial comparing inpatient and outpatient administration of high-dose cisplatin. Internal Medicine Journal, 41(2), 172-178. [More Information]
Tebbutt, N., Murphy, F., Zannino, D., Wilson, C., Parry, M., Abdi, E., Strickland, A., Lowenthal, R., Marx, G., Karapetis, C., Shannon, J., Simes, R., et al (2011). Risk of arterial thromboembolic events in patients with advanced colorectal cancer receiving bevacizumab. Annals of Oncology, 22(8), 1834-1838. [More Information]
Farrar, D., Duley, L., Burls, A., Dorling, J., Embleton, N., McGuire, W., Oddie, S., Simes, R., Tarnow-Mordi, W., Thornton, J., et al (2011). Rushing to clamp umbilical cord: More evidence is needed to inform practice. BMJ: British Medical Journal, 342(Letters), d122-d122. [More Information]
Clarke, S., Yip, S., Brown, C., van Hazel, G., Ransom, D., Goldstein, D., Jeffrey, G., Tebbutt, N., Buck, M., Lowenthal, R., Boland, A., Gebski, V., Simes, R., et al (2011). Single-agent irinotecan or 5-fluorouracil and leucovorin (FOLFIRI) as second-line chemotherapy for advanced colorectal cancer; results of a randomised phase II study (DaVINCI) and meta-analysis. European Journal of Cancer, 47(12), 1826-1836. [More Information]
Sjoquist, K., Burmeister, B., Smithers, B., Zalcberg, J., Simes, R., Barbour, A., Gebski, V. (2011). Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. The Lancet Oncology, 12(7), 681-692. [More Information]
Simes, R., Voysey, M., O'Connell, R., Glasziou, P., Best, J., Scott, R., Pardy, C., Byth Wilson, K., Sullivan, D., Ehnholm, C., Keech, A. (2010). A novel method to adjust efficacy estimates for uptake of other active treatments in long-term clinical trials. PloS One, 5(1), e8580-1-e8580-10. [More Information]
Taskinen, M., Barter, P., Ehnholm, C., Sullivan, D., Robledo, K., Simes, R., Best, J., Hamwood, S., Keech, A. (2010). Ability of traditional lipid ratios and apolipoprotein ratios to predict cardiovascular risk in people with type 2 diabetes. Diabetologia, 53(9), 1846-1855. [More Information]
De Roock, W., Jonker, D., Di Nicolantonio, F., Sartore-Bianchi, A., Tu, D., Siena, S., Lamba, S., Arena, S., Frattini, M., Piessevaux, H., Simes, R., et al (2010). Association of KRAS p.G13D Mutation With Outcome in Patients With Chemotherapy-Refractory Metastatic Colorectal Cancer Treated With Cetuximab. JAMA - Journal of the American Medical Association, 304(16), 1812-1820. [More Information]
Tebbutt, N., Wilson, K., Gebski, V., Cummins, M., Zannino, D., van Hazel, G., Robinson, B., Broad, A., Ganju, V., Ackland, S., Stockler, M., Simes, R., et al (2010). Capecitabine, Bevacizumab and Mitomycin in First-Line Treatment of Metastatic Colorectal Cancer: Results of the Australasian Gastrointestinal Trials Group Randomized, Phase III MAX Study. Journal of Clinical Oncology, 28(19), 3191-3198. [More Information]
Van Glabbeke, M., Verweij, J., Blay, J., Debiec-Rychter, M., Demetri, G., Heinrich, M., Borden, E., Blanke, C., Crowley, J., Rankin, C., Zalcberg, J., Simes, R., et al (2010). Comparison of Two Doses of Imatinib for the Treatment of Unresectable or Metastatic Gastrointestinal Stromal Tumors: A Meta-Analysis of 1,640 Patients. Journal of Clinical Oncology, 28(7), 1247-1253. [More Information]
Grimison, P., Stockler, M., Thomson, D., Olver, I., Harvey, V., Gebski, V., Lewis, C., Levi, J., Boyer, M., Gurney, H., Boland, A., Simes, R., et al (2010). Comparison of Two Standard Chemotherapy Regimens for Good-Prognosis Germ Cell Tumors: Updated Analysis of a Randomized Trial. Journal of the National Cancer Institute, 102(16), 1253-1262. [More Information]
Davis, T., Ting, R., Best, J., Donoghoe, M., Drury, P., Sullivan, D., Jenkins, A., O'Connell, R., Whiting, M., Glasziou, P., Simes, R., Gebski, V., Keech, A., et al (2010). Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia, 54(2), 280-290. [More Information]
Baigent, C., Blackwell, L., Emberson, J., Holland, L., Reith, C., Bhala, N., Peto, R., Barnes, E., Keech, A., Simes, R., et al (2010). Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised trials. The Lancet, 376(9753), 1670-1681. [More Information]
Lee, C., Lord, S., Stockler, M., Coates, A., Gebski, V., Simes, R. (2010). Historical cross-trial comparisons for competing treatments in advanced breast cancer - An empirical analysis of bias. European Journal of Cancer, 46(3), 541-548. [More Information]
de Boer, S., Westerhout, C., Simes, R., Granger, C., Zijlstra, F., Boersma, E. (2010). Mortality and Morbidity Reduction by Primary Percutaneous Coronary Intervention Is Independent of the Patient's Age. J A C C: Cardiovascular Interventions, 3(3), 324-331. [More Information]
Lee, C., Stockler, M., Coates, A., Gebski, V., Lord, S., Simes, R. (2010). Self-reported health-related quality of life is an independent predictor of chemotherapy treatment benefit and toxicity in women with advanced breast cancer. British Journal of Cancer, 102(9), 1341-1347. [More Information]
Cui, J., Forbes, A., Kirby, A., Marschner, I., Simes, R., Hunt, D., West, M., Tonkin, A. (2010). Semi-parametric risk prediction models for recurrent cardiovascular events in the LIPID study. BMC Medical Research Methodology, 10(27), 27-1-27-9. [More Information]
Askie, L., Baur, L., Campbell, K., Daniels, L., Hesketh, K., Magarey, A., Mihrshahi, S., Rissel, C., Simes, R., Taylor, B., Voysey, M., et al (2010). The Early Prevention of Obesity in CHildren (EPOCH) Collaboration - an Individual Patient Data Prospective Meta-Analysis. BMC Public Health, 10, 728-1-728-8. [More Information]
Califf, R., Armstrong, P., Granger, C., Harrington, R., Lee, K., Simes, R., van de Werf, F., Wallentin, L., White, H. (2010). Towards a new order in cardiovascular medicine: re-engineering through global collaboration. European Heart Journal, 31(8), 911-917. [More Information]
Simes, R., O'Connell, R., Aylward, P., Varshavsky, S., Diaz, R., Wilcox, R., Armstrong, P., Granger, C., French, J., Van de Werf, F., Marschner, I., et al (2010). Unexplained international differences in clinical outcomes after acute myocardial infarction and fibrinolytic therapy: Lessons from the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. American Heart Journal, 159(6), 988-997. [More Information]
Grimison, P., Simes, R., Hudson, M., Stockler, M. (2009). Deriving a Patient-Based Utility Index from a Cancer-Specific Quality of Life Questionnaire. Value in Health, 12(5), 800-807. [More Information]
Cui, J., Forbes, A., Kirby, A., Simes, R., Tonkin, A. (2009). Laboratory and non-laboratory-based risk prediction models for secondary prevention of cardiovascular disease: the LIPID study. European Journal of Cardiovascular Prevention and Rehabilitation, 16(6), 660-668. [More Information]
Soderberg, S., Colquhoun, D., Keech, A., Yallop, J., Barnes, E., Pollicino, C., Simes, R., Tonkin, A., Nestel, P. (2009). Leptin, but not adiponectin, is a predictor of recurrent cardiovascular events in men: results from the LIPID study. International Journal of Obesity, 33(1), 123-130. [More Information]
Lee, C., Lord, S., Coates, A., Simes, R. (2009). Molecular biomarkers to individualise treatment: assessing the evidence. Medical Journal of Australia, 190(11), 631-636. [More Information]
Grimison, P., Simes, R., Hudson, M., Stockler, M. (2009). Preliminary Validation of an Optimally Weighted Patient-Based Utility Index by Application to Randomized Trials in Breast Cancer. Value in Health, 12(6), 967-976. [More Information]
Mittman, N., Au, H., Tu, D., O'Callaghan, C., Isogai, P., Karapetis, C., Zalcberg, J., Evans, W., Moore, M., Siddiqui, J., Simes, R., Tebbutt, N., et al (2009). Prospective Cost-Effectiveness Analysis of Cetuximab in Metastatic Colorectal Cancer: Evaluation of National Cancer Institute of Canada Clinical Trials Group CO.17 Trial. Journal of the National Cancer Institute, 101(17), 1182-1192. [More Information]
Taskinen, M., Sullivan, D., Ehnholm, C., Whiting, M., Zannino, D., Simes, R., Keech, A., Barter, P. (2009). Relationships of HDL cholesterol, ApoA-I, and ApoA-II with homocysteine and creatinine in patients with Type 2 diabetes treated with fenofibrate. Arteriosclerosis, Thrombosis, and Vascular Biology, 29(6), 950-955. [More Information]
Gill, G., Wetzig, N., Gebski, V., Stockler, M., Ung, O., Campbell, I., Simes, R. (2009). Sentinel-Lymph-Node-Based Management or Routine Axillary Clearance? One-Year Outcomes of Sentinel Node Biopsy Versus Axillary Clearance (SNAC): A Randomized Controlled Surgical Trial. Annals of Surgical Oncology, 16(2), 266-275. [More Information]
Berger, J., Elliott, L., Gallup, D., Roe, M., Granger, C., Armstrong, P., Simes, R., White, H., Van de Werf, F., Topol, E., et al (2009). Sex Differences in Mortality Following Acute Coronary Syndromes. JAMA - Journal of the American Medical Association, 302(8), 874-882. [More Information]
Carrick, S., Parker, S., Thornton, C., Ghersi, D., Simes, R., Wilcken, N. (2009). Single agent versus combination chemotherapy for metastatic breast cancer. Cochrane Database of Systematic Reviews, (2), CD003372-1-CD003372-109. [More Information]
Clarke, P., Hayes, A., Glasziou, P., Scott, R., Simes, R., Keech, A. (2009). Using the EQ-5D index score as a predictor of outcomes in patients with type 2 diabetes. Medical Care, 47(1), 61-68. [More Information]
Hayes, A., Clarke, P., Glasziou, P., Simes, R., Drury, P., Keech, A. (2008). Can self-rated health scores be used for risk prediction in patients with type 2 diabetes? Diabetes Care, 31(4), 795-797. [More Information]
Smith, M., Gill, P., Wetzig, N., Sourjina, T., Gebski, V., Ung, O., Campbell, I., Kollias, J., Coskinas, X., Macphee, A., Simes, R., Stockler, M., et al (2008). Comparing patients' and clinicians' assessment of outcomes in a randomised trial of sentinel node biopsy for breast cancer (the RACS SNAC trial). Breast Cancer Research and Treatment, 117(1), 99-109. [More Information]
Duric, V., Butow, P., Sharpe, L., Heritier, S., Boyle, F., Beith, J., Wilcken, N., Coates, A., Simes, R., Stockler, M. (2008). Comparing patients' and their partners' preferences for adjuvant chemotherapy in early breast cancer. Patient Education and Counseling, 72(2), 239-245. [More Information]
Stewart, R., North, F., Sharples, K., Simes, R., Tonkin, A., White, H. (2008). Differences in cardiovascular mortality between Australia and New Zealand according to socioeconomic status: findings from the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study. New Zealand Medical Journal, 121(1269), 11-23.
Kearney, P., Blackwell, L., Collins, R., Keech, A., Simes, R., Peto, R., Armitage, J., Baigent, C. (2008). Efficacy of cholesterol-lowering therapy in 18 686 people with diabetes in 14 randomised trials of statins: a meta-analysis. The Lancet, 371, 117-125. [More Information]
Keech, A., Mitchell, P., Summanen, P., Davis, T., Simes, R. (2008). Fenofibrate and diabetic retinopathy - Authors' reply. The Lancet, 371(9614), 722-722. [More Information]
Berger, J., Stebbins, A., Granger, C., Ohman, E., Armstrong, P., Van de Werf, F., White, H., Simes, R., Harrington, R., Califf, R., et al (2008). Initial Aspirin Dose and Outcome Among ST-Elevation Myocardial Infarction Patients Treated With Fibrinolytic Therapy. Circulation, 117(2), 192-199. [More Information]
Karapetis, C., Khambata-Ford, S., Jonker, D., O'Callaghan, C., Tu, D., Tebbutt, N., Simes, R., Chalchal, H., Shapiro, J., Robitaille, S., et al (2008). K-ras Mutations and Benefit from Cetuximab in Advanced Colorectal Cancer. New England Journal of Medicine, 359(17), 1757-1765. [More Information]
Glasziou, P., Irwig, L., Heritier, S., Simes, R., Tonkin, A. (2008). Monitoring cholesterol levels: Measurement error or true change? Annals of Internal Medicine, 148(9), 656-661. [More Information]
Cui, J., Forbes, A., Kirby, A., Marschner, I., Simes, R., West, M., Tonkin, A. (2008). Parametric conditional frailty models for recurrent cardiovascular events in the lipid study. Clinical Trials, 5(6), 565-574. [More Information]
Kearney, P., Keech, A., Simes, R., Collins, R. (2008). Statins and diabetes: authors' reply. The Lancet, 371(9626), 1752-1752.
Dwan, K., Altman, D., Arnaiz, J., Bloom, J., Chan, A., Cronin, E., Decullier, E., Easterbrook, P., Von Elm, E., Gamble, C., Ghersi, D., Simes, R., et al (2008). Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias. PloS One, 3(8), e3081-1-e3081-31. [More Information]
Lord, S., Lee, C., Simes, R. (2008). The Role of Predictive and Prognostic Markers in Cancer. Cancer Forum, 32(3), 139-142.
West, M., Nestel, P., Kirby, A., Schnabel, R., Sullivan, D., Simes, R., Pollicino, C., Lubos, E., Munzel, T., White, H., et al (2008). The value of N-terminal fragment of brain natriuretic peptide and tissue inhibitor of metalloproteinase-1 levels as predictors of cardiovascular outcome in the LIPID study. European Heart Journal, 29(7), 923-931. [More Information]
Lord, S., Irwig, L., Simes, R. (2007). A philosophical approach to diagnostic test evaluation - In Response. Annals of Internal Medicine, 146(10), 757-758.
Marschner, I., Simes, R., Keech, A. (2007). Biases in the Identification of Risk Factor Thresholds and J-Curves. American Journal of Epidemiology, 166(7), 824-831. [More Information]
Smith, M., Gill, P., Wetzig, N., Sourjina, T., Simes, R., Stockler, M. (2007). Bs06 patient-rated outcome measures were more sensitive than clinician-rated measures at distinguishing the effects of sentinel node biopsy and axillary clearance in the snac trial. ANZ Journal of Surgery, 77(Suppl. 1), A2-A2. [More Information]
Mark, D., Van de Werf, F., Simes, R., White, H., Wallentin, L., Califf, R., Armstrong, P. (2007). Cardiovascular disease on a global scale: defining the path forward for research and practice. European Heart Journal, 28(21), 2678-2684. [More Information]
Jonker, D., Oâ€™Callaghan, C., Karapetis, C., Zalcberg, J., Tu, D., Au, H., Berry, S., Krahn, M., Price, T., Simes, R., et al (2007). Cetuximab for the Treatment of Colorectal Cancer. New England Journal of Medicine, 357(20), 2040-2048. [More Information]
Grimison, P., Simes, R., Stockler, M. (2007). Development and validation of optimally weighted measures of global health-related quality of life (QoL) and utility based on a cancer-specific QoL instrument. Value in Health, 10(6), A226-A227.
Keech, A., Mitchell, P., Summanen, P., O'Day, J., Davis, T., Moffitt, M., Taskinen, M., Simes, R., Tse, D., Williamson, E., Merrifield, A., O'Connell, R., et al (2007). Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. The Lancet, 370(9600), 1687-1697. [More Information]
Stockler, M., O'Connell, R., Nowak, A., Goldstein, D., Turner, J., Wilcken, N., Wyld, D., Abdi, E., Glasgow, A., Beale, P., Dhillon, H., Heritier, S., Carter, C., Hickie, I., Simes, R., et al (2007). Effect of sertraline on symptoms and survival in patients with advanced cancer, but without major depression: a placebo-controlled double-blind randomised trial. The Lancet Oncology, 8(7), 603-612. [More Information]
Timmer, J., Ottervanger, J., de Boer, M., Boersma, E., Grines, C., Westerhout, C., Simes, R., Granger, C., Zijlstra, F., Primary Coronary Angioplasty vs Thrombolysisâ€“2 Trialists, C. (2007). Primary percutaneous coronary intervention compared with fibrinolysis for myocardial infarction in diabetes mellitus: results from the Primary Coronary Angioplasty vs Thrombolysis-2 trial. Archives of Internal Medicine, 167(13), 1353-1359. [More Information]
Duric, V., Butow, P., Sharpe, L., Boyle, F., Beith, J., Wilcken, N., Heritier, S., Coates, A., Simes, R., Stockler, M. (2007). Psychosocial factors and patients' preferences for adjuvant chemotherapy in early breast cancer. Psycho-Oncology, 16(1), 48-59. [More Information]
Gebski, V., Burmeister, B., Smithers, B., Foo, K., Zalcberg, J., Simes, R. (2007). Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. The Lancet Oncology, 8(3), 226-234. [More Information]
Edmond, J., French, J., Aylward, P., Wong, C., Stewart, R., Williams, B., de Pasquale, C., O'Connell, R., van den Berg, K., Van de Werf, F., Simes, R., et al (2007). Variations in the use of emergency PCI for the treatment of re-infarction following intravenous fibrinolytic therapy: impact on outcomes in HERO-2. European Heart Journal, 28(12), 1418-1424. [More Information]
Stockler, M., Sourjina, T., Harvey, V., Frances, P., Byrne, M., van Hazel, G., Fitzharris, B., Ackland, S., Finch, K., Lindsay, D., Gebski, V., Simes, R., Coates, A., et al (2006). A randomized trial of capecitabine given intermittently versus continuously versus classical CMF as first line chemotherapy for women with advanced breast cancer unsuited to more intensive treatment. Breast Cancer Research and Treatment, 100(Supplement 1), S278-S278.
Keech, A., Simes, R. (2006). Clinical trial design & management: The role of PPAR-ALPHA agonists in prevention of CVD. Atherosclerosis Supplements, 7(3), 174-174.
Keech, A., Simes, R., Barter, P., Best, J., Scott, R., Taskinen, M. (2006). Correction to the FIELD study report. The Lancet, 368(9545), 1415. [More Information]
Tonkin, A., Eckermann, S., White, H., Friedlander, D., Glasziou, P., Magnus, P., Kirby, A., Mulray, S., Denton, M., Sallaberger, M., Simes, R., et al (2006). Cost-effectiveness of cholesterol-lowering therapy with pravastatin in patients with previous acute coronary syndromes aged 65 to 74 years compared with younger patients: results from the LIPID study. American Heart Journal, 151(6), 1305-1312. [More Information]
Stockler, M., Tattersall, M., Boyer, M., Clarke, S., Beale, P., Simes, R. (2006). Disarming the guarded prognosis: predicting survival in newly referred patients with incurable cancer. British Journal of Cancer, 94(2), 208-212. [More Information]
Boersma, E., Westerhout, C., Simes, R., Weaver, W., Andersen, H., Armstrong, P., Granger, C., Grines, C., Zijlstra, F., Widimsky, P., et al (2006). Does time matter? A pooled analysis of randomized clinical trials comparing primary percutaneous coronary intervention and in-hospital fibrinolysis in acute myocardial infarction patients. European Heart Journal, 27(7), 779-788. [More Information]
Baigent, C., Keech, A., Kearney, P., Collins, R., Simes, R. (2006). Efficacy and safety of cholesterol-lowering treatment - Reply. The Lancet, 367(9509), 470-471.
Baigent, C., Keech, A., Kearney, P., Collins, R., Simes, R. (2006). Efficacy and safety of cholesterol-lowering treatment-authors' reply [letter]. The Lancet, 367(9509), 470-471. [More Information]
Edmond, J., French, J., Stewart, R., Aylward, P., de Pasquale, C., Williams, B., O'Connell, R., Simes, R., White, H. (2006). Frequency of recurrent ST-elevation myocardial infarction after fibrinolytic therapy in a different territory as a manifestation of multiple unstable coronary arterial plaques. American Journal of Cardiology, 97(7), 947-951. [More Information]
Alexander, K., Newby, L., Bhapkar, M., White, H., Hochman, J., Pfisterer, M., Moliterno, D., Peterson, E., Van de Werf, F., Simes, R., Keech, A., et al (2006). International variation in invasive care of the elderly with acute coronary syndromes. European Heart Journal, 27(13), 1558-1564. [More Information]
Tonelli, M., Isles, C., Craven, T., Furberg, C., Tonkin, A., Pfeffer, M., Shepherd, J., Cobbe, S., Sacks, F., Simes, R., et al (2006). Letter regarding article by Tonelli et al, "Effect of pravastatin on rate of kidney function loss in people with or at risk for coronary disease" - Response. Circulation Journal, 113, e59-e60. [More Information]
Galbraith, S., Marschner, I., Simes, R. (2006). Missing data methods for the assessment of surrogate outcomes and treatment mechanisms in clinical trial substudies. Statistics in Medicine, 25(3), 415-431. [More Information]
Stocker, R., Pollicino, C., Gay, C., Nestel, P., Colquhoun, D., Whiting, M., Tonkin, A., Sullivan, D., Simes, R. (2006). Neither plasma coenzyme Q(10) concentration, nor its decline during pravastatin therapy, is linked to recurrent cardiovascular disease events: A prospective case-control study from the LIPID study. Atherosclerosis, 187(1), 198-204. [More Information]
Orlandini, A., Diaz, R., Wojdyla, D., Pieper, K., Van de Werf, F., Granger, C., Harrington, R., Boersma, E., Califf, R., Armstrong, P., Simes, R., et al (2006). Outcomes of patients in clinical trials with ST-segment elevation myocardial infarction among countries with different gross national incomes. European Heart Journal, 27(5), 527-533. [More Information]
Van Glabbeke, M., Verweij, J., Casali, P., Simes, R., Le Cesne, A., Reichardt, P., Issels, R., Judson, I., van Oosterom, A., Blay, J. (2006). Predicting toxicities for patients with advanced gastrointestinal stromal tumours treated with imatinib: a study of the European Organisation for Research and Treatment of Cancer, the Italian Sarcoma Group, and the Australasian Gastro-Intestinal Trials Gr. European Journal of Cancer, 42(14), 2277-2285. [More Information]
Askie, L., Ghersi, D., Simes, R. (2006). Prospective registration of clinical trials [Editorial]. Australian Journal of Physiotherapy, 52(4), 237-239. [More Information]
Gill, P., Gebski, V., Wetzig, N., Ung, O., Campbell, I., Collins, J., Sourjina, T., Coskinas, X., Stockler, M., Simes, R. (2006). Sentinel node (SN) based management causes less arm swelling and better quality of life than routine axillary clearance (AC): 1 year outcomes of the SNAC trial. Breast Cancer Research and Treatment, 100(Supplement 1), S14-S14.
Bushnell, C., Griffin, J., Newby, L., Goldstein, L., Mahaffey, K., Graffagnino, C., Harrington, R., White, H., Simes, R., Califf, R., et al (2006). Statin use and sex-specific stroke outcomes in patients with vascular disease. Stroke, 37(6), 1427-1431. [More Information]
Gebski, V., Lagleva, M., Keech, A., Simes, R., Langlands, A. (2006). Survival Effects of Postmastectomy Adjuvant Radiation Therapy Using Biologically Equivalent Doses: A Clinical Perspective - [Response]. Journal of the National Cancer Institute, 98(17), 1021-1022. [More Information]
Gebski, V., Lagleva, M., Keech, A., Simes, R., Langlands, A. (2006). Survival effects of postmastectomy adjuvant radiation therapy using biologically equivalent doses: a clinical perspective. Journal of the National Cancer Institute, 98(1), 26-38. [More Information]
Keech, A., Simes, R., Barter, P., Best, J., Scott, R., Taskinen, M. (2006). The FIELD study - Reply. The Lancet, 367(9517), 1142-1143. [More Information]
Lord, S., Irwig, L., Simes, R. (2006). When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials? Annals of Internal Medicine, 144(11), 850-855. [More Information]
Ackland, S., Jones, M., Tu, D., Simes, R., Yuen, J., Sargeant, A., Dhillon, H., Goldberg, R., Abdi, E., Moore, M., et al (2005). A meta-analysis of two randomised trials of early chemotherapy in asymptomatic metastatic colorectal cancer. British Journal of Cancer, 93(11), 1236-1243. [More Information]
O'Connell, R., Edmond, J., French, J., Aylward, P., Simes, R., White, H. (2005). A simple prognostic score for the re-infarction risk following fibrinolytic therapy for myocardial infarction - data from HERO-2. European Heart Journal, 26(Suppl 1), 561-561.
Ghersi, D., Wilcken, N., Simes, R. (2005). A systematic review of taxane-containing regimens for metastatic breast cancer. British Journal of Cancer, 93(3), 293-301. [More Information]
West, M., Blankenberg, S., Simes, R., Pollicino, C., Kirby, A., Nestel, P., White, H., Tonkin, A. (2005). Brain natriuretic peptide: a predictor of cardiovascular outcome in the Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) study. European Heart Journal, 26(Suppl 1), 718-718.
Duric, V., Stockler, M., Butow, P., Sharpe, L., Heritier, S., Beith, J., Boyle, F., Wilcken, N., Coates, A., Simes, R. (2005). Comparing patients' and their partners' preferences for adjuvant chemotherapy (ACT) in early breast cancer (EBC). Journal of Clinical Oncology, 23(16S), 546S-546S.
Sinnaeve, P., Simes, R., Yusuf, S., Garg, J., Mehta, S., Eikelboom, J., Bittl, J., Serruys, P., Topol, E., Granger, C. (2005). Direct thrombin inhibitors in acute coronary syndromes: effect in patients undergoing early percutaneous coronary intervention. European Heart Journal, 26(22), 2396-403. [More Information]
Tonelli, M., Keech, A., Shepherd, J., Sacks, F., Tonkin, A., Packard, C., Pfeffer, M., Simes, R., Isles, C., Furberg, C., et al (2005). Effect of pravastatin in people with chronic kidney disease and diabetes mellitus. Hypertension, 46(4), 900-901.
Tonelli, M., Keech, A., Shepherd, J., Sacks, F., Tonkin, A., Packard, C., Pfeffer, M., Simes, R., Isles, C., Furberg, C., et al (2005). Effect of pravastatin in people with diabetes and chronic kidney disease. Journal of the American Society of Nephrology, 16(12), 3748-3754. [More Information]
Tonelli, M., Isles, C., Craven, T., Tonkin, A., Pfeffer, M., Shepherd, J., Sacks, F., Furberg, C., Cobbe, S., Simes, R., et al (2005). Effect of pravastatin on rate of kidney function loss in people with or at risk for coronary disease. Circulation, 112(2), 171-178. [More Information]
Keech, A., Simes, R., Barter, P., Best, J., Scott, R., Taskinen, M., Forder, P., Pillai, A., Davis, T., Glasziou, P., Sullivan, D., MacMahon, S., et al (2005). Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. The Lancet, 366(9500), 1849-1861. [More Information]
Baigent, C., Keech, A., Kearney, P., Blackwell, L., Buck, G., Pollicino, C., Kirby, A., Sourjina, T., Peto, R., Collins, R., Simes, R. (2005). Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. The Lancet, 366(9493), 1267-1278. [More Information]
Scott, R., Best, J., Forder, P., Taskinen, M., Simes, R., Barter, P., Keech, A. (2005). Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate (ISRCTN64783481). Cardiovascular Diabetology, 4(13), 1-9. [More Information]
Armstrong, P., Newby, L., Granger, C., Lee, K., Califf, R., Simes, R., Van de Werf, F., White, H. (2005). Letter regarding article by Armstrong et al, "Lessons learned from a clinical trial" - Response. Circulation, 111(23), e393-e393.
Labinaz, M., Mathias, J., Pieper, K., Granger, C., Lincoff, A., Moliterno, D., Van de Werf, F., Simes, R., White, H., Simoons, M., et al (2005). Outcomes of patients with acute coronary syndromes and prior percutaneous coronary intervention: a pooled analysis of three randomized clinical trials. European Heart Journal, 26(2), 128-136. [More Information]
Wong, C., French, J., Aylward, P., Stewart, R., Gao, W., Van de Werf, F., Armstrong, P., Simes, R., Raffel, O., Granger, C., et al (2005). Patients With Prolonged Ischemic Chest Pain and Presumed-New Left Bundle Branch Block Have Heterogeneous Outcomes Depending on the Presence of ST-Segment Changes. Journal of the American College of Cardiology, 46(1), 29-38. [More Information]
Duric, V., Stockler, M., Heritier, S., Boyle, F., Beith, J., Sullivan, A., Wilcken, N., Coates, A., Simes, R. (2005). Patients' preferences for adjuvant chemotherapy in early breast cancer: what makes AC and CMF worthwhile now? Annals of Oncology, 16(11), 1786-1794. [More Information]
Nestel, P., Baghurst, K., Colquhoun, D., Simes, R., Mehalski, K., White, H., Tonkin, A., Kirby, A., Pollicino, C. (2005). Relation of diet to cardiovascular disease risk factors in subjects with cardiovascular disease in Australia and New Zealand: analysis of the Long-Term Intervention with Pravastatin in Ischaemic Disease trial. American Journal of Clinical Nutrition, 81(6), 1322-1329. [More Information]
Carrick, S., Parker, S., Thornton, C., Ghersi, D., Simes, R., Wilcken, N. (2005). Single agent versus combination chemotherapy for metastatic breast cancer (Review). Cochrane Database of Systematic Reviews, 2005 (2), 1-22. [More Information]
Burmeister, B., Smithers, B., Gebski, V., Fitzgerald, L., Simes, R., Devitt, P., Ackland, S., Gotley, D., Joseph, D., Millar, J., Walpole, E., et al (2005). Surgery alone versus chemoradiotherapy followed by surgery for resectable cancer of the oesophagus: a randomised controlled phase III trial. The Lancet Oncology, 6(9), 659-668. [More Information]
Ghersi, D., Wilcken, N., Simes, R., Donoghue, E. (2005). Taxane containing regimens for metastatic breast cancer (Review). Cochrane Database of Systematic Reviews, 2005 (2), 1-119. [More Information]
Nestel, P., Blankenberg, S., Simes, R., Kirby, A., Tonkin, A. (2005). Tissue inhibitor of metalloproteinase (TIMP-1) is a predictor of recurrent cardiovascular events in the LIPID study. European Heart Journal, 26(Suppl 1), 257-257.
Stewart, R., White, H., Kirby, A., Heritier, S., Simes, R., Nestel, P., West, M., Colquhoun, D., Tonkin, A. (2005). White Blood Cell Count Predicts Reduction in Coronary Heart Disease Mortality With Pravastatin. Circulation, 111(14), 1756-1762. [More Information]
Cox, K., O'Connell, R., Stockler, M., Boyer, M., Beale, P., Simes, R. (2004). A randomized crossover trial of giving high-dose cisplatin with or without an overnight stay in hospital: Patients' preferences, quality of life, safety and resource use. Journal of Clinical Oncology, 22(14S), 547S-547S.
Lord, S., Ghersi, D., Gattellari, M., Wilcken, N., Thornton, C., Simes, J. (2004). Antitumour Antibiotic Containing Regimens For Metastatic Breast Cancer. Cochrane Database of Systematic Reviews, 4(CD003367), 1-123.
Boersma, E., Simes, R., Grines, C., Westerhout, C. (2004). Does time matter? Individual patient data-based meta-analysis of primary PCI versus fibrinolysis in acute myocardial infarction randomized trials. Circulation, 110(Suppl III), III 539-III 539.
Colquhoun, D., Keech, A., Hunt, D., Marschner, I., Simes, R., Glasziou, P., White, H., Barter, P., Tonkin, A. (2004). Effects Of Pravastatin On Coronary Events In 2073 Patients With Low Levels Of Both Low-Density Lipoprotein Cholesterol And High-Density Lipoprotein Cholesterol: Results From The Lipid Study. European Heart Journal, 25(9), 771-777. [More Information]
Kassem-Moussa, H., Mahaffey, K., Graffagnino, C., Tassisa, G., Sila, C., Simes, R., White, H., Califf, R., Bhapkar, M., Newby, L. (2004). Incidence and characteristics of stroke during 90-day follow-up in patients stabilized after an acute coronary syndrome. American Heart Journal, 148(3), 439-446. [More Information]
Armstrong, P., Newby, L., Granger, C., Lee, K., Simes, R., Van de Werf, F., White, H., Califf, R. (2004). Lessons learned from a clinical trial. Circulation, 110(23), 3610-3614. [More Information]
Carrick, S., Ghersi, D., Wilcken, N., Simes, R. (2004). Platinum Containing Regimens For Metastatic Breast Cancer. Cochrane Database of Systematic Reviews, 2(CD003374), 1-74.
Duric, V., Stockler, M., Butow, P., Sharpe, L., Beith, J., Sullivan, A., Boyle, F., Dhillon, H., Coates, A., Simes, R. (2004). Predictors of the benefits women consider necessary to make adjuvant chemotherapy (ACT) worthwhile for early breast cancer (EBC). Journal of Clinical Oncology, 22(14S), 73S-73S.
Kandzari, D., Granger, C., Simoons, M., White, H., Simes, R., Mahaffey, K., Gore, J., Weaver, W., Longstreth, W., Stebbins, A., et al (2004). Risk Factors For Intracranial Hemorrhage And Nonhemorrhagic Stroke After Fibrinolytic Therapy (From The Gusto-I Trial). American Journal of Cardiology, 93(4), 458-461. [More Information]
Keech, A., Best, J., Scott, R., Barter, P., Simes, R., Forder, P., Taskinen, M., FIELD study investigators, F. (2004). Significant lipid changes in a large-scale trial of fenofibrate to prevent cardiovascular disease in type 2 diabetes. Journal of the American College of Cardiology, 43(5), A462-A462.
Simes, R., Gebski, V., Keech, A. (2004). Subgroup analysis: application to individual patient decisions. Medical Journal of Australia, 180(9), 467-469. [More Information]
Barter, P., Best, J., Coleman, P., D'Emden, M., Davis, T., Drury, P., Ehnholm, C., Keech, A., Simes, R., et al (2004). The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Cardiovascular Diabetology, 3(December), 9 - 1-9 - 11. [More Information]
Glare, P., Virik, K., Jones, M., Hudson, M., Eychmuller, S., Simes, R., Christakis, N. (2003). A systematic review of physicians' survival predictions in terminally ill cancer patients. BMJ: British Medical Journal, 327(195), 195-198.
Magliano, D., Liew, D., Pater, H., Kirby, A., Hunt, D., Simes, R., Sundararajan, V., Tonkin, A. (2003). Accuracy of the Australian National Death Index: comparison with adjudicated fatal outcomes among Australian participants in the long-term intervention with Pravastatin in Ischaemic Disease (LIPID) Study. Australian and New Zealand Journal of Public Health, 27(6), 649-653. [More Information]
Pike, R., Keech, A., Simes, R. (2003). Clinical trials research in the new millennium: the International Clinical Trials Symposium, Sydney, 21-23 October 2002. Medical Journal of Australia, 178(7), 316-317.
Stewart, R., North, F., West, T., Sharples, K., Simes, R., Colquhoun, D., White, H., Tonkin, A. (2003). Depression and cardiovascular morbidity and mortality: cause or consequence? European Heart Journal, 24, 2027-2037. [More Information]
Hague, W., Forder, P., Simes, R., Hunt, D., Tonkin, A. (2003). Effect of pravastatin on cardiovascular events and mortality in 1516 women with coronary heart disease: Results from the Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) study. American Heart Journal, 145(4), 643-651. [More Information]
Kramer, J., Newby, L., Chang, W., Simes, R., Van de Werf, F., Granger, C., Lee, K., White, H., Piegas, L., Topol, E., et al (2003). International variation in the use of evidence-based medicines for acute coronary syndromes. European Heart Journal, 24(23), 2133-2141. [More Information]
Patel, A., Jones, M., Simes, R., Topol, E., Califf, R., Van, D., Betriu,, A., Ardissino,, D., Armstrong, P., Aylward, P., et al (2003). Primary coronary angioplasty compared with intravenous thrombolytic therapy for acute myocardial infarction: six-month follow up and analysis of individual patient data from randomized trials. American Heart Journal, 145(1), 48-57. [More Information]
Keech, A., Colquhoun, D., Best, J., Kirby, A., Simes, R., Hunt, D., Hague, W., Beller, E., Arulchelvam, M., Baker, J., et al (2003). Secondary prevention of cardio vascular events with long-term Pravastatin in patients with diabetes or impared fasting glucose: results from the LIPID trial. Diabetes Care, 26(10), 2713-2721. [More Information]
Ghersi, D., Wilcken, N., Simes, R., Donoghue, E. (2003). Taxane containing regimes for metastatic breast cancer. Cochrane Database of Systematic Reviews, 168(37), 3117-3120. [More Information]
Eckermann, S., Martin, A., Stockler, M., Simes, R. (2003). The benefits and costs of tamoxifen for breast cancer prevention. Australian and New Zealand Journal of Public Health, 27(1), 34-40. [More Information]
Coates, A., Thompson, J., McMullen, A., Simes, R., McCarthy, W., Hersey, P., Sillar, R., Mcleod, R., Gill, P., Coventry, B., Dhillon, H. (2002). Adjuvant Immunotherapy of Patients with High-Risk Melanoma Using Vaccinia Viral Lysates of Melanoma: Results of a Randomized Trial. Journal of Clinical Oncology, 20(20), 4181-4189.
Glasziou, P., Eckermann, S., Mulray, S., Simes, R., Martin, A., Kirby, A., Hall, J., White, H., Caleo, S., Tonkin, A. (2002). Cholesterol-lowering therapy with pravastatin in patients with average cholesterol levels and establisheed ischaemic heart disease: is it cost effective? Medical Journal of Australia, 177(8), 428-434. [More Information]
Zijlstra, F., Patel, A., Jones, W., Grines, C., Ellis, S., Garcia, E., Grinfeld, L., Gibbons, R., Ribeiro, E., Ribichini, F., Simes, R., et al (2002). Clinical characteristics and outcome of patients with early(<2h), intermediate (2-4h) and late (>4h) presentation treated by primary coronary angioplasty or thrombolytic therapy for acute myocardial infarction. European Heart Journal, 23(7), 550-557.
Simes, R., Furberg, C., Braunwald, E., Davis, B., Ford, I., Tonkin, A., Shepherd, J., Keech, A. (2002). Effects of pravastatin on mortality in patients with and without coronary heart disease across a broad range of cholesterol levels. European Heart Journal, 23(3), 207-215. [More Information]
Cuzick, J., Forbes, J., Edwards, R., Baum, M., Cawthorn, S., Coates, A., Hamed, H., Howell, A., Powels, T., Dhillon, H., Gebski, V., Simes, R. (2002). First results from the International Breast Cancer Intervention Study (IBIS-1): a randomised prevention trial. The Lancet, 360(9336), 817-824. [More Information]
Simes, R., Kirby, A., Keech, A., Hague, W., MacMahon, S., Hunt, D., Tonkin, A., Alyward, P., Colquhoun, D., Glasziou, P., et al (2002). Long-term effectiveness and safety of pravastatin in 9014 patients with coronary heart disease and average cholesterol concentrations: the LIPID trial follow up. The Lancet, 359, 1379-1387. [More Information]
Boersma, E., Harrington, R., Moliterno, D., White, H., Theroux, P., Van de Werf, F., Torbal, A., Armstrong, P., Wallentin, L., Wilcox, R., Simes, R., et al (2002). Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: a meta-analysis of all major randomised clinical trials. The Lancet, 359(9302), 189-198. [More Information]
Simes, R., Keech, A., et al (2002). Randomized, placebo-controlled trial of titrated intravenous lamifiban for acute coronary syndromes. Circulation, 105(3), 316-321.
Simes, R., Marschner, I., Hunt, D., Sullivan, D., Colquhoun, D., Hague, W., Stewart, R., Keech, A., Thompson, P., White, H., et al (2002). Relationship between lipid levels and clinical outcomes in the long-term intervention with pravastatin in ischemic disease (LIPID) trial: to what extent is the reduction in coronary events with pravastatin explained by on-study lipid levels? Circulation, 105(10), 1162-1169. [More Information]
West, M., White, H., Simes, R., Kirby, A., Watson, J., Anderson, N., Hankey, G., Simes, S., Hunt, D., Tonkin, A. (2002). Risk factors for non-haemorraghic stroke in patients with coronary heart disease and the effect of lipid-modifying therapy with pravastatin. Journal of Hypertension, 20(12), 2513-2517. [More Information]
Al-Khatib, S., Huang, Y., Califf, R., Lee, K., Simoons, M., Van de Werf, F., White, H., Simes, R., Granger, C., Armstrong, P., et al (2002). Sustained ventricular arrythmias among patients with acute coronary syndromes with no ST-segment elevation: incidence, predictors and outcomes. Circulation, 106(3), 309-312. [More Information]
Armstrong, P., Newby, L., Califf, R., White, H., Harrington, R., Van de Werf, F., Granger, C., Simes, R., Hasselblad, V. (2002). The failure of orally administered glycoprotein IIb/IIIa inhibitors to prevent recurrent cardiac events. The American Journal of Medicine, 112(8), 647-658. [More Information]
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, C., Liberati, A., et al (2001). Addition of drug/s to a chemotherapy regimen for metastatic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Basser, R., Henderson, I., Brunswick, C., Fossati, R., Liberati, A., et al (2001). Antitumor antibiotic containing regimins for metastatic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Hunt, D., Young, P., Simes, R., Hague, W., Mann, S., Owensby, D., Lane, G., Tonkin, A. (2001). Benefits of pravastatin on cardiovascular events and mortality in older patients with coronary heart disease are equal to or exceed those seen in younger patients. Annals of Internal Medicine, (134), 931-940.
Simes, R., Hague, W., Young, P., Hunt, D., Mann, S., Owensby, D., Lande,, G., Tonkin, A. (2001). Benefits of pravastatin on cardiovascular events and mortalty in older patients with coronary heart disease are equpal to or exceed those seen isn younder patients: results from LIPID Trial. Annals of Internal Medicine, 134 (10), 931-940.
Lumley, T., Simes, R., Gebski, V., Hudson, H. (2001). Combining components of quality of life to increase precision and evaluate trade-offs. Statistics in Medicine, 20(21), 3231-3249. [More Information]
Toner, G., Stockler, M., Boyer, M., Jones, M., Thomson, D., Harvey, V., Olver, I., Dhillon, H., McMullen, A., Gebski, V., Levi, J., Simes, R. (2001). Comparison of two standard chemotherapy regimens for good-prognosis germ-cell tumours: a randomised trial. The Lancet, 357(9528), 739-745. [More Information]
Jeffery, H., Simes, R., Lawrence, G., Tudehope, D., Baumann,, K., Gill, A., Cole, M., Drew, J., McPhee,, A., Ratcliffe, J., et al (2001). Enteral human IgG for prevention of necrotising enterocolitis: a placebo-controlled, randomised trial. The Lancet, 357, 2090-2094.
Gebski, V., Veness, M., Simes, R., Shakespeare, T. (2001). Improving interpretation of clinical studies by use of confidence intervals, clinical significnce cureves, and risk analysis. The Lancet, 357, 1349-1353.
Shakespeare, T., Gebski, V., Veness, M., Simes, R. (2001). Improving interpretation of clinical studies by use of confidence levels, clinical significance curves, and risk-benefit contours. The Lancet, 357(9265), 1349-1353.
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, R., Liberati, A., et al (2001). Larger vs smaller dose of the same drug/s regimen for metastatic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Marschner, I., Simes, R., Colquhoun, D., Glasziou, P., Harris, P., Singh, B., Friedlander, D., White, H., Thompson, P., Tonkin, A. (2001). Long-term risk stratification for survivors of acute coronary syndromes. Journal of the American College of Cardiology, 38(1), 56-63. [More Information]
Simes, R., Coates, A. (2001). Patient preferences for adjuvant chemotherapy of early breast cancer: How much benefit is needed? Journal of the National Cancer Institute, 30, 146-152. [More Information]
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, R., Liberati, A., et al (2001). Platinum containing reimens for metastatic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, R., Liberati, A., et al (2001). Single agent vs combination chemotherapy for metastatic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, C., Liberati, A., et al (2001). Taxane containing regimens for metastatsic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, R., Liberati, A., et al (2001). Two drug combinations vs combinations of 3 or more cytotoxic drugs for meastatic brest cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Stockler, M., Wilcken, N., Ghersi, D., Simes, R. (2000). Systematic reviews of chemotherapy and endocrine therapy in metastatic breast cancer. Cancer Treatment Reviews, 26(3), 151-168. [More Information]

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Conferences

Sullivan, D., Forder, P., Simes, R., Whiting, M., Keech, A. (2006). Individual and combined effects of fenofibrate and sulphonylureas on HDL cholesterol and outcomes. XIV International Symposium on Atherosclerosis, Ireland: Elsevier Ireland Ltd.
Colquhoun, D., Soderberg, S., Kirby, A., Keech, A., Simes, R., Hague, W., Hamilton-Craig, I., Tonkin, A. (2006). Obesity and adipokines as risk factors for major coronary heart disease events in patients with CHD: Results from the lipid trial. XIV International Symposium on Atherosclerosis, Ireland: Elsevier Ireland Ltd.
Gebski, V., Lagleva, M., Simes, R., Keech, A., Langlands, A. (2005). Adjuvant Radiotherapy in Early Breast Cancer: The Clinical Utility of Published Meta-Analysis. RANZCR, 55th Annual Scientific Meeting.
Gebski, V., Heritier, S., Pillai, A., Luke, V., Simes, R., Keech, A. (2005). Computer modelling of adaptive randomisation schemes in large scale randomised controlled trials. 20th International Workshop on Statistical Modelling, Sydney, Australia: University of Western Sydney.
Gebski, V., Simes, R. (2002). Survival plots for interpreting trial results. International Clinical Trials Symposium.

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By Year

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2024

Mersiades, T., Solomon, B., Thomas, D., Lee, C., Parry, M., Sebastian, L., Ballinger, M., Collignon, E., Turnbull, O., Yip, S., Morton, R., Brown, C., Itchins, M., Simes, R., Pavlakis, N., et al (2024). ASPiRATION: Australian observational cohort study of comprehensive genomic profiling in metastatic lung cancer tissue. Future Oncology, 20(7), 361-371. [More Information]
Brown, B., Galpin, K., Simes, R., Boyer, M., Brown, C., Chin, V., Young, J. (2024). Development of clinically meaningful quality indicators for contemporary lung cancer care, and piloting and evaluation in a retrospective cohort; experiences of the Embedding Research (and Evidence) in Cancer Healthcare (EnRICH) Program. BMJ Open, 14(2), e074399. [More Information]
Dakic, A., Wu, J., Wang, T., Huynh, K., Mellett, N., Duong, T., Beyene, H., Yang, J., Figtree, G., Simes, R., et al (2024). Imputation of plasma lipid species to facilitate integration of lipidomic datasets. Nature Communications, 15(1), 1540. [More Information]
Mihaylova, B., Wu, R., Zhou, J., Williams, C., Schlackow, I., Emberson, J., Reith, C., Keech, A., Robson, J., Simes, R. (2024). Lifetime effects and cost-effectiveness of standard and higher-intensity statin therapy across population categories in the UK: a microsimulation modelling study. The Lancet Regional Health. Europe, 40, 100887. [More Information]
Wu, R., Gray, A., Simes, R., Baigent, C., Mihaylova, B., Williams, C., Zhou, J., Schlackow, I., Emberson, J., Reith, C., Keech, A., et al (2024). Long-term cardiovascular risks and the impact of statin treatment on socioeconomic inequalities: a microsimulation model. British Journal of General Practice, 74(740), e189-e198. [More Information]
Vasconcelos, J., Moore, M., Karapetis, C., Siu, L., Shapiro, J., Simes, R., Gill, S., O’Callaghan, C., Loree, J., Chen, N., et al (2024). Transverse Colon Primary Tumor Location as a Biomarker in Metastatic Colorectal Cancer: A Pooled Analysis of CCTG/AGITG CO.17 and CO.20 Randomized Clinical Trials. Clinical Cancer Research, 30(6), 1121-1130. [More Information]

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2023

Campbell, I., Wetzig, N., Ung, O., Espinoza, D., Farshid, G., Collins, J., Kollias, J., Gebski, V., Mister, R., Simes, R., Stockler, M., et al (2023). 10-Year axillary recurrence in the RACS SNAC1 randomised trial of sentinel lymph node-based management versus routine axillary lymph node dissection. Breast, 70, 70-75. [More Information]
Thavaneswaran, S., Kansara, M., Lin, F., Espinoza, D., Grady, J., Lee, C., Ballinger, M., Sebastian, L., Corpuz, T., Qiu, M., Bailey, C., Schmitz, U., Simes, R., et al (2023). A signal-seeking Phase 2 study of olaparib and durvalumab in advanced solid cancers with homologous recombination repair gene alterations. British Journal of Cancer, 129(3), 475-485. [More Information]
Agar, M., Nowak, A., Hovey, E., Barnes, E., Simes, R., Vardy, J., Wheeler, H., Kong, B., Leonard, R., Hall, M., Tim, E., Spyridopoulos, D., Sim, H., et al (2023). Acetazolamide versus placebo for cerebral oedema requiring dexamethasone in recurrent and/or progressive high-grade glioma: phase II randomised placebo-controlled double-blind study. BMJ Supportive and Palliative Care, 13(3), 354-362. [More Information]
Brown, B., Galpin, K., Simes, R., Boyer, M., Chin, V., Young, J. (2023). Clinicians' Evaluation of Lung Cancer Clinical Quality Indicators and Comparative Performance Data in Practice. European Journal of Cancer Care, 2023, 6636704. [More Information]
Zhang, J., Kong, W., Hu, P., Jonker, D., Moore, M., Ringash, J., Shapiro, J., Zalcberg, J., Simes, R., Tu, D., et al (2023). Clustering on longitudinal quality-of-life measurements using growth mixture models for clinical prognosis: Implementation on CCTG/AGITG CO.20 trial. Cancer Medicine, 12(5), 6117-6128. [More Information]
Kansara, M., Bhardwaj, N., Thavaneswaran, S., Xu, C., Lee, J., Chang, L., Madison, R., Lin, F., Hsu, E., Patel, V., Simes, R., et al (2023). Early circulating tumor DNA dynamics as a pan-tumor biomarker for long-term clinical outcome in patients treated with durvalumab and tremelimumab. Molecular Oncology, 17(2), 298-311. [More Information]
Tang, M., Pearson, S., Simes, R., Chua, B. (2023). Harnessing Real-World Evidence to Advance Cancer Research. Current Oncology, 30(2), 1844-1859. [More Information]
Lam, L., Pavlakis, N., Shitara, K., Sjoquist, K., Martin, A., Yip, S., Kang, Y., Bang, Y., Chen, L., Moehler, M., Hague, W., Gebski, V., Jaworski, A., Simes, R., et al (2023). INTEGRATE II: randomised phase III controlled trials of regorafenib containing regimens versus standard of care in refractory Advanced Gastro-Oesophageal Cancer (AGOC): a study by the Australasian Gastro-Intestinal Trials Group (AGITG). BMC Cancer, 23(1). [More Information]
Zeverijn, L., Looze, E., Thavaneswaran, S., van Berge Henegouwen, J., Simes, R., Hoes, L., Sjoquist, K., van der Wijngaart, H., Sebastian, L., Geurts, B., Lee, C., Espinoza, D., Lin, F., et al (2023). Limited clinical activity of palbociclib and ribociclib monotherapy in advanced cancers with cyclin D-CDK4/6 pathway alterations in the Dutch DRUP and Australian MoST trials. International Journal of Cancer, 153(7), 1413-1422. [More Information]
M. Naeini, M., Newell, F., Aoude, L., Bonazzi, V., Patel, K., Lampe, G., Koufariotis, L., Lakis, V., Addala, V., Kondrashova, O., Wilson, K., Barnes, E., Simes, R., Gebski, V., et al (2023). Multi-omic features of oesophageal adenocarcinoma in patients treated with preoperative neoadjuvant therapy. Nature Communications, 14(1), 3155. [More Information]
Sim, H., Wachsmuth, L., Barnes, E., Yip, S., Koh, E., Hall, M., Jennens, R., Kong, B., Simes, R., Khasraw, M., et al (2023). NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma. Neuro-Oncology Advances, 5(1), vdad124. [More Information]
Day, D., Toh, H., Ali, R., Foo, E., Simes, R., Chia, J., Segelov, E. (2023). Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial. JCO Global Oncology, 9, e2300040. [More Information]
Mercieca-Bebber, R., Eggins, R., Brown, K., Gebski, V., Brewer, K., Lai, L., Bailey, L., Solomon, M., Lumley, J., Hewett, P., Wilson, K., Hague, W., Simes, R., Stevenson, A., et al (2023). Patient-Reported Bowel, Urinary, and Sexual Outcomes After Laparoscopic-Assisted Resection or Open Resection for Rectal Cancer: The Australasian Laparoscopic Cancer of the Rectum Randomized Clinical Trial (ALaCart). Annals of Surgery, 277(3), 449-455. [More Information]
Zhou, J., Wu, R., Williams, C., Emberson, J., Reith, C., Keech, A., Robson, J., Armitage, J., Gray, A., Simes, R., et al (2023). Prediction Models for Individual-Level Healthcare Costs Associated with Cardiovascular Events in the UK. PharmacoEconomics, 41(5), 547-559. [More Information]
Seidler, A., Willson, M., Aberoumand, M., Williams, J., Hunter, K., Barba, A., Simes, R., Webster, A. (2023). The changing landscape of clinical trials in Australia. Medical Journal of Australia, 219(5), 192-196. [More Information]
Tarnow-Mordi, W., Robledo, K., Marschner, I., Seidler, A., Simes, R. (2023). To guide future practice, perinatal trials should be much larger, simpler and less fragile with close to 100% ascertainment of mortality and other key outcomes. Seminars in Perinatology, 47(5), 151789. [More Information]
Sjoquist, K., Martin, A., Pavlakis, N., Goldstein, D., Tsobanis, E., Moses, D., Maher, R., Hague, W., Gebski, V., Stockler, M., Simes, R. (2023). Value of central review of RECIST v1.1 outcomes in the AGITG INTEGRATE randomised phase 2 international trial for advanced oesophago-gastric cancer. Journal of Cancer Research and Clinical Oncology, 149, 4959-4965. [More Information]

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2022

Morton, R., Tuffaha, H., Novakova, V., Spencer, J., Hawley, C., Peyton, P., Higgins, A., Marsh, J., Taylor, W., Huckson, S., Simes, R., et al (2022). Approaches to prioritising research for clinical trial networks: a scoping review. Trials, 23(1). [More Information]
Law, C., Stevenson, A., Solomon, M., Hague, W., Simes, R., Morton, R. (2022). ASO Author Reflections: Is laparoscopic-Assisted Surgery More Costly than Traditional Open Resection for Rectal Cancer Treatment? Annals of Surgical Oncology, 29(3), 1935-1936. [More Information]
Nicholls, D., Xu, M., Kaneswaran, L., Grant, B., Brown, M., Shapiro, J., Karapetis, C., Simes, R., Jonker, D., Tu, D., et al (2022). Assessment of Successful Randomization Through a Machine Learning and Visualization Tool for Pre-treatment Symptoms: Examples from CCTG/AGITG CO.17 and CO.20 Trials. Revue d'Intelligence Artificielle, 36(6), 913-918. [More Information]
Stewart, R., Kirby, A., White, H., Marschner, S., West, M., Thompson, P., Sullivan, D., Janus, E., Hunt, D., Kritharides, L., Keech, A., Simes, R., et al (2022). B-Type Natriuretic Peptide and Long-Term Cardiovascular Mortality in Patients With Coronary Heart Disease. Journal of the American Heart Association, 11(13). [More Information]
Coskinas, X., Simes, R., Martin, A. (2022). Changes to design and analysis elements of research plans during randomised controlled trials in Australia. Medical Journal of Australia, 217(10), 526-531. [More Information]
West, M., Kirby, A., Stewart, R., Blankenberg, S., Sullivan, D., White, H., Hunt, D., Marschner, I., Janus, E., Kritharides, L., Simes, R., et al (2022). Circulating Cystatin C Is an Independent Risk Marker for Cardiovascular Outcomes, Development of Renal Impairment, and Long-Term Mortality in Patients With Stable Coronary Heart Disease: The LIPID Study. Journal of the American Heart Association, 11(5), e020745. [More Information]
Thompson, P., Hui, J., Beilby, J., Palmer, L., Watts, G., West, M., Kirby, A., Marschner, S., Simes, R., Sullivan, D., et al (2022). Common genetic variants do not predict recurrent events in coronary heart disease patients. BMC Cardiovascular Disorders, 22(1), 96-1-96-9. [More Information]
Singh, K., Batich, K., Wen, P., Tan, A., Bagley, S., Lim, M., Platten, M., Colman, H., Ashley, D., Chang, S., Simes, R., et al (2022). Designing Clinical Trials for Combination Immunotherapy: A Framework for Glioblastoma. Clinical Cancer Research, 28(4), 585-593. [More Information]
Robledo, K., Tarnow-Mordi, W., Rieger, I., Suresh, P., Martin, A., Yeung, C., Ghadge, A., Liley, H., Osborn, D., Morris, J., Hague, W., Kluckow, M., Keech, A., Kirby, A., Simes, R., et al (2022). Effects of delayed versus immediate umbilical cord clamping in reducing death or major disability at 2 years corrected age among very preterm infants (APTS): a multicentre, randomised clinical trial. The Lancet Child and Adolescent Health, 6(3), 150-157. [More Information]
Cho, D., Cheyne, S., Lord, S., Simes, R., Lee, C. (2022). Extrapolating evidence for molecularly targeted therapies from common to rare cancers: a scoping review of methodological guidance. BMJ Open, 12(7). [More Information]
Keane, C., O'Grady, G., Bissett, I., Hayes, J., Hulme-Moir, M., Eglinton, T., Solomon, M., Lumley, J., Simes, R., Stevenson, A. (2022). Functional Outcome of Laparoscopic-Assisted Resection Versus Open Resection of Rectal Cancer: A Secondary Analysis of the Australasian Laparoscopic Cancer of the Rectum Trial. Diseases of the Colon and Rectum, 65(7), E698-E706. [More Information]
Tang, M., Lee, C., Lewis, C., Boyer, M., Brown, B., Schaffer, A., Pearson, S., Simes, R. (2022). Generalizability of immune checkpoint inhibitor trials to real-world patients with advanced non-small cell lung cancer. Lung Cancer, 166, 40-48. [More Information]
Law, C., Stevenson, A., Solomon, M., Hague, W., Wilson, K., Simes, R., Morton, R. (2022). Healthcare Costs of Laparoscopic versus Open Surgery for Rectal Cancer Patients in the First 12 Months: A Secondary Endpoint Analysis of the Australasian Laparoscopic Cancer of the Rectum Trial (ALaCaRT). Annals of Surgical Oncology, 29(3), 1923-1934. [More Information]
Kong, B., Sim, H., Barnes, E., Nowak, A., Hovey, E., Jeffree, R., Harrup, R., Parkinson, J., Gan, H., Pinkham, M., Yip, S., Hall, M., Tu, E., Carter, C., Simes, R., et al (2022). Multi-Arm GlioblastoMa Australasia (MAGMA): Protocol for a multiarm randomised clinical trial for people affected by glioblastoma. BMJ Open, 12(9). [More Information]
Cho, D., Lord, S., Simes, R., Cooper, W., Friedlander, M., Bae, S., Lee, C. (2022). Next-generation sequencing, should I use anti-HER2 therapy for HER2-amplified tumors off-label? Illustrating an extrapolation framework. Therapeutic Advances in Medical Oncology, 14. [More Information]
Mercieca-Bebber, R., Barnes, E., Wilson, K., Samoon, Z., Walpole, E., Mai, T., Ackland, S., Burge, M., Dickie, G., Watson, D., Wang, T., Simes, R., Gebski, V., et al (2022). Patient-reported outcome (PRO) results from the AGITG DOCTOR trial: a randomised phase 2 trial of tailored neoadjuvant therapy for resectable oesophageal adenocarcinoma. BMC Cancer, 22(1), 276-1-276-11. [More Information]
Greenham, L., Bennett, P., Dansie, K., Mister, R., Smyth, B., Westall, P., Herzog, S., Brown, C., Simes, R., Morton, R., et al (2022). The Symptom Monitoring with Feedback Trial (SWIFT): protocol for a registry-based cluster randomised controlled trial in haemodialysis. Trials, 23(1), 419. [More Information]
Woodford, R., Zhou, D., Kok, P., Lord, S., Friedlander, M., Marschner, I., Simes, R., Lee, C. (2022). The validity of progression-free survival 2 as a surrogate trial end point for overall survival. Cancer, 128(7), 1449-1457. [More Information]
Chionh, F., Gebski, V., Al-Obaidi, S., Mooi, J., Bruhn, M., Lee, C., Chüeh, A., Williams, D., Weickhardt, A., Wilson, K., Simes, R., et al (2022). VEGF-A, VEGFR1 and VEGFR2 single nucleotide polymorphisms and outcomes from the AGITG MAX trial of capecitabine, bevacizumab and mitomycin C in metastatic colorectal cancer. Scientific Reports, 12(1), 1238-1-1238-14. [More Information]

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2021

Sim, H., McDonald, K., Lwin, Z., Barnes, E., Rosenthal, M., Foote, M., Koh, E., Back, M., Wheeler, H., Sulman, E., Buckland, M., Fisher, L., Leonard, R., Hall, M., Yip, S., Simes, R., Khasraw, M., et al (2021). A randomized phase II trial of veliparib, radiotherapy, and temozolomide in patients with unmethylated MGMT glioblastoma: The VERTU study. Neuro-Oncology, 23(10), 1736-1749. [More Information]
Oar, A., Lee, M., Le, H., Wilson, K., Aiken, C., Chantrill, L., Simes, R., Nguyen, N., Barbour, A., Samra, J., Sjoquist, K., Espinoza, D., Gebski, V., Yip, S., Kneebone, A., Goldstein, D., et al (2021). AGITG MASTERPLAN: a randomised phase II study of modified FOLFIRINOX alone or in combination with stereotactic body radiotherapy for patients with high-risk and locally advanced pancreatic cancer. BMC Cancer, 21(1), 936. [More Information]
Tang, M., Pearson, S., Schaffer, A., Lewis, C., John, T., Simes, R., Lee, C. (2021). Are clinical trial eligibility criteria representative of older patients with lung cancer? A population-based data linkage study. Journal of Geriatric Oncology, 12(6), 930-936. [More Information]
Tang, M., Schaffer, A., Kiely, B., Daniels, B., Lee, C., Simes, R., Pearson, S. (2021). Cardiac assessment in Australian patients receiving (neo)adjuvant trastuzumab for HER2-positive early breast cancer: a population-based study. Breast Cancer Research and Treatment, 187(3), 893-902. [More Information]
Petit, C., Lacas, B., Pignon, J., Le, Q., Gregoire, V., Grau, C., Hackshaw, A., Zackrisson, B., Parmar, M., Lee, J., et al (2021). Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis. The Lancet Oncology, 22(5), 727-736. [More Information]
Lin, F., Thavaneswaran, S., Grady, J., Ballinger, M., Oakes, S., Desai, J., Lee, C., Simes, R., Thomas, D. (2021). Criteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology. n p j Precision Oncology, 5(1), 58. [More Information]
Tan, A., Askie, L., Hunter, K., Barba, A., Simes, R., Seidler, A. (2021). Data sharing—trialists' plans at registration, attitudes, barriers and facilitators: A cohort study and cross-sectional survey. Research Synthesis Methods, 12(5), 641-657. [More Information]
Orkin, A., Gill, P., Ghersi, D., Campbell, L., Sugarman, J., Emsley, R., Steg, P., Weijer, C., Simes, R., Rombey, T., et al (2021). Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement. JAMA - Journal of the American Medical Association, 326(3), 257-265. [More Information]
Briffa, T., Symons, T., Zeps, N., Straiton, N., Tarnow-Mordi, W., Simes, R., Harris, I., Cruz, M., Webb, S., Litton, E., et al (2021). Normalising comparative effectiveness trials as clinical practice. Trials, 22(1), 620. [More Information]
Field, K., Barnes, E., Sim, H., Nowak, A., Simes, R., Rosenthal, M., Wheeler, H., Hovey, E., Cher, L. (2021). Outcomes from the use of computerized neurocognitive testing in a recurrent glioblastoma clinical trial. Journal of Clinical Neuroscience, 94, 321-327. [More Information]
Coskinas, X., Schou, M., Simes, R., Martin, A. (2021). Reacting to prognostic covariate imbalance in randomised controlled trials. Contemporary Clinical Trials, 110, 106544-1-106544-7. [More Information]
Januszewski, A., Chen, D., Scott, R., O'Connell, R., Aryal, N., Sullivan, D., Watts, G., Taskinen, M., Barter, P., Best, J., Simes, R., Keech, A., Jenkins, A. (2021). Relationship of low molecular weight fluorophore levels with clinical factors and fenofibrate effects in adults with type 2 diabetes. Scientific Reports, 11(1), 18708. [More Information]
Law, C., Brewer, K., Brown, C., Wilson, K., Bailey, L., Hague, W., Simes, R., Stevenson, A., Solomon, M., Morton, R. (2021). Return to work following laparoscopic-assisted resection or open resection for rectal cancer: Findings from AlaCaRT—Australasian Laparoscopic Cancer of the Rectum Trial. Cancer Medicine, 10(2), 552-562. [More Information]
Tan, A., Bagley, S., Wen, P., Lim, M., Platten, M., Colman, H., Ashley, D., Wick, W., Chang, S., Galanis, E., Simes, R., et al (2021). Systematic review of combinations of targeted or immunotherapy in advanced solid tumors. Journal for ImmunoTherapy of Cancer, 9(7), e002459. [More Information]

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2020

Coskinas, X., Simes, R., Schou, M., Martin, A. (2020). Changes to aspects of ongoing randomised controlled trials with fixed designs. Trials, 21(1), 457. [More Information]
Tang, M., Schaffer, A., Kiely, B., Daniels, B., Simes, R., Lee, C., Pearson, S. (2020). Correction: Treatment patterns and survival in HER2-positive early breast cancer: a whole-of-population Australian cohort study (2007-2016). British Journal of Cancer, 123(5), 868. [More Information]
Hilvo, M., Meikle, P., Pedersen, E., Tell, G., Dhar, I., Brenner, H., Schottker, B., Laaperi, M., Kauhanen, D., Koistinen, K., Sullivan, D., Simes, R., et al (2020). Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients. European Heart Journal, 41(3), 371-380. [More Information]
Cipriani, A., Ioannidis, J., Rothwell, T., Glasziou, P., Li, T., Hernandez, A., Tomlinson, A., Simes, R., Naci, H. (2020). Generating comparative evidence on new drugs and devices after approval. The Lancet, 395(10228), 998-1010. [More Information]
Grimison, P., Mersiades, T., Kirby, A., Lintzeris, N., Morton, R., Haber, P., Olver, I., Walsh, A., McGregor, I., Cheung, Y., Simes, R., Stockler, M., et al (2020). Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial. Annals of Oncology, 31(11), 1553-1560. [More Information]
Barbour, A., Walpole, E., Mai, G., Barnes, E., Watson, D., Acland, S., Martin, J., Burge, M., Finch, R., Karapetis, C., Falk, G., Gebski, V., Oostendorp, M., Wilson, K., Simes, R., et al (2020). Preoperative cisplatin, fluorouracil, and docetaxel with or without radiotherapy after poor early response to cisplatin and fluorouracil for resectable oesophageal adenocarcinoma (AGITG DOCTOR): results from a multicentre, randomised controlled phase II trial. Annals of Oncology, 31(2), 236-245. [More Information]
Fulcher, J., Keech, A., Simes, R., Baigent, C., Collins, R. (2020). Questioning statin therapy for older patients – Authors' reply. The Lancet, 395(10240), 1832-1833. [More Information]
Seidler, A., Duley, L., Katheria, A., De Paco Matallana, C., Dempsey, E., Rabe, H., Kattwinkel, J., Mercer, J., Josephsen, J., Fairchild, K., Tarnow-Mordi, W., Kluckow, M., Hunter, K., Barba, A., Simes, R., Askie, L., et al (2020). Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): Study protocol. BMJ Open, 10(3), e034595. [More Information]
Tarnow-Mordi, W., Abdel-Latif, M., Martin, A., Pammi, M., Robledo, K., Manzoni, P., Osborn, D., Lui, K., Keech, A., Hague, W., Ghadge, A., Brown, R., Isaacs, D., Gordon, A., Askie, L., Deshpande, G., Tracy, M., Sinn, J., Simes, R., et al (2020). The effect of lactoferrin supplementation on death or major morbidity in very low birthweight infants (LIFT): a multicentre, double-blind, randomised controlled trial. The Lancet Child and Adolescent Health, 4(6), 444-454. [More Information]
Cao, J., Waldman, B., O'Connell, R., Sullivan, D., Scott, R., Aryal, N., Gebski, V., Marschner, I., Taskinen, M., Simes, R., McGill, N., Jenkins, A., Keech, A. (2020). Uric acid predicts long-term cardiovascular risk in type 2 diabetes but does not mediate the benefits of fenofibrate: The FIELD study. Diabetes, Obesity and Metabolism, 22(8), 1388-1396. [More Information]
Kok, P., Cho, D., Yoon, W., Ritchie, G., Marschner, I., Lord, S., Friedlander, M., Simes, R., Lee, C. (2020). Validation of Progression-Free Survival Rate at 6 Months and Objective Response for Estimating Overall Survival in Immune Checkpoint Inhibitor Trials: A Systematic Review and Meta-analysis. JAMA Network Open, 3(9), e2011809. [More Information]

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2019

Simes, R., Martin, A. (2019). Assumptions, damn assumptions and statistics. Annals of Oncology, 30(9), 1415-1416. [More Information]
Tang, M., Joensuu, H., Simes, R., Price, T., Yip, S., Hague, W., Sjoquist, K., Zalcberg, J. (2019). Challenges of international oncology trial collaboration-a call to action. British Journal of Cancer, 121(7), 515-521. [More Information]
Jayawardana, K., Mundra, P., Giles, C., Barlow, C., Nestel, P., Barnes, E., Kirby, A., Thompson, P., Sullivan, D., Alshehry, Z., Marschner, I., Simes, R., et al (2019). Changes in plasma lipids predict pravastatin efficacy in secondary prevention. JCI Insight, 4(13), 1-13. [More Information]
Stevenson, A., Solomon, M., Brown, C., Lumley, J., Hewett, P., Clouston, A., Gebski, V., Wilson, K., Hague, W., Simes, R. (2019). Disease-free Survival and Local Recurrence After Laparoscopic-assisted Resection or Open Resection for Rectal Cancer: The Australasian Laparoscopic Cancer of the Rectum Randomized Clinical Trial. Annals of Surgery, 269(4), 596-602. [More Information]
Ackland, S., Gebski, V., Zdenkowski, N., Wilson, A., Green, M., Tees, S., Dhillon, H., van Hazel, G., Levi, J., Simes, R., Coates, A., et al (2019). Dose intensity in anthracycline-based chemotherapy for metastatic breast cancer: mature results of the randomised clinical trial ANZ 9311. Breast Cancer Research and Treatment, 176(2), 357-365. [More Information]
Tang, M., Chen, J., Goldstein, D., Links, M., Lord, S., Marschner, I., Simes, R., Lee, C. (2019). Evaluation of Phase II Trial Design in Advanced Pancreatic Cancer. Pancreas, 48(10), 1274-1284. [More Information]
Wells, J., Tu, D., Siu, L., Shapiro, J., Jonker, D., Karapetis, C., Simes, R., Liu, G., Price, T., Tebbutt, N., et al (2019). Outcomes of Older Patients (> 70 Years) Treated With Targeted Therapy in Metastatic Chemorefractory Colorectal Cancer: Retrospective Analysis of NCIC CTG CO17 and CO20. Clinical Colorectal Cancer, 18(1), e140-e149. [More Information]
Tan, A., Jiang, I., Askie, L., Hunter, K., Simes, R., Seidler, A. (2019). Prevalence of trial registration varies by study characteristics and risk of bias. Journal of Clinical Epidemiology, 113, 64-74. [More Information]
Simes, J., Kirby, A., Tonkin, A. (2019). Response by Simes et al to Letter Regarding Article, "D-Dimer Predicts Long-Term Cause-Specific Mortality, Cardiovascular Events, and Cancer in Patients With Stable Coronary Heart Disease". Circulation, 139(9), 1245-1246. [More Information]
Dauzier, E., Lacas, B., Blanchard, P., Le, Q., Simon, C., Wolf, G., Janot, F., Horiuchi, M., Tobias, J., Moon, J., Simes, R., et al (2019). Role of chemotherapy in 5000 patients with head and neck cancer treated by curative surgery: A subgroup analysis of the meta-analysis of chemotherapy in head and neck cancer. Oral Oncology, 95, 106-114. [More Information]
Lassman, A., van den Bent, M., Gan, H., Reardon, D., Kumthekar, P., Butowski, N., Lwin, Z., Mikkelsen, T., Nabors, L., Papadopoulos, K., Simes, J., et al (2019). Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro-Oncology, 21(1), 106-114. [More Information]
Tang, M., Schaffer, A., Kiely, B., Daniels, B., Simes, R., Lee, C., Pearson, S. (2019). Treatment patterns and survival in HER2-positive early breast cancer: a whole-of-population Australian cohort study (2007-2016). British Journal of Cancer, 121(11), 904-911. [More Information]
Olafson, L., Siddell, A., Field, K., Byrnes, M., Rapkins, R., Ng, B., Nixdorf, S., Barnes, E., Johns, T., Yip, S., Simes, R., et al (2019). Whole genome and biomarker analysis of patients with recurrent glioblastoma on bevacizumab: A subset analysis of the CABARET trial. Journal of Clinical Neuroscience, 70, 157-163. [More Information]

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2018

Ameratunga, M., Pavlakis, N., Wheeler, H., Grant, R., Simes, R., Khasraw, M. (2018). Anti-angiogenic therapy for high-grade glioma. Cochrane Database of Systematic Reviews, 2018 (11), 1-52. [More Information]
Askie, L., Darlow, B., Finer, N., Schmidt, B., Stenson, B., Tarnow-Mordi, W., Davis, P., Carlo, W., Brocklehurst, P., Davies, L., Gebski, V., Hunter, K., Simes, R., et al (2018). Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA, 319(21), 2190-2201. [More Information]
Willeit, P., Ridker, P., Nestel, P., Simes, R., Tonkin, A., Pedersen, T., Schwartz, G., Olsson, A., Colhoun, H., Kronenberg, F., et al (2018). Baseline and on-statin treatment lipoprotein(a) levels for prediction of cardiovascular events: individual patient-data meta-analysis of statin outcome trials. The Lancet, 392(10155), 1311-1320. [More Information]
Thavaneswaran, S., Sebastian, L., Ballinger, M., Best, M., Hess, D., Lee, C., Sjoquist, K., Hague, W., Butow, P., Simes, R., et al (2018). Cancer Molecular Screening and Therapeutics (MoST): a framework for multiple, parallel signal-seeking studies of targeted therapies for rare and neglected cancers. Medical Journal of Australia, 209(8), 354.e1-354.e6. [More Information]
Rankin, N., Lai, M., Miller, D., Beale, P., Spigelman, A., Prest, G., Turley, K., Simes, R. (2018). Cancer multidisciplinary team meetings in practice: Results from a multi-institutional quantitative survey and implications for policy change. Asia-Pacific Journal of Clinical Oncology, 14(1), 74-83. [More Information]
Shapiro, J., Thavaneswaran, S., Underhill, C., Robledo, K., Karapetis, C., Day, F., Nott, L., Jefford, M., Chantrill, L., Pavlakis, N., Khasraw, M., Simes, R., Gebski, V., et al (2018). Cetuximab Alone or With Irinotecan for Resistant KRAS-, NRAS-, BRAF- and PIK3CA-wild-type Metastatic Colorectal Cancer: The AGITG Randomized Phase II ICECREAM Study. Clinical Colorectal Cancer, 17(4), 313-319. [More Information]
Field, K., Fitt, G., Rosenthal, M., Simes, R., Nowak, A., Barnes, E., Sawkins, K., Goh, C., Moffat, B., Salinas, S., et al (2018). Comparison between site and central radiological assessments for patients with recurrent glioblastoma on a clinical trial. Asia-Pacific Journal of Clinical Oncology, 14(5), e359-e365. [More Information]
Simes, R., Robledo, K., White, H., Espinoza, D., Stewart, R., Sullivan, D., Zeller, T., Hague, W., Nestel, P., Glasziou, P., Keech, A., et al (2018). D-dimer Predicts Long-Term Cause-Specific Mortality, Cardiovascular Events and Cancer in Patients with Stable Coronary Heart Disease: LIPID Study. Circulation, 138(7), 712-723. [More Information]
Fogarty, M., Osborn, D., Askie, L., Seidler, A., Hunter, K., Lui, K., Simes, R., Tarnow-Mordi, W. (2018). Delayed Versus Early Umbilical Cord Clamping for Preterm Infants: A Systematic Review and Meta-Analysis. American Journal of Obstetrics and Gynecology, 218(1), 1-18. [More Information]
Tarnow-Mordi, W., Morris, J., Kirby, A., Robledo, K., Askie, L., Brown, R., Evans, N., Finlayson, S., Fogarty, M., Gebski, V., Ghadge, A., Hague, W., Isaacs, D., Jeffery, M., Keech, A., Kluckow, M., Popat, H., Sebastian, L., Liley, H., Osborn, D., Simes, R., et al (2018). Delayed Versus Immediate Cord Clamping in Preterm Infants. Obstetrical and Gynecological Survey, 73(5), 265-266. [More Information]
Lawrence, N., Roncolato, F., Martin, A., Simes, R., Stockler, M. (2018). Effect Sizes Hypothesized and Observed in Contemporary Phase III Trials of Targeted and Immunological Therapies for Advanced Cancer. JNCI Cancer Spectrum, 2(4). [More Information]
Martin, A., Gibbs, E., Sjoquist, K., Pavlakis, N., Simes, R., Price, T., Shannon, J., Gill, S., Jain, V., Liu, G., et al (2018). Health-related quality of life associated with regorafenib treatment in refractory advanced gastric adenocarcinoma. Gastric Cancer, 21(3), 473-480. [More Information]
Mundra, P., Barlow, C., Nestel, P., Barnes, E., Kirby, A., Thompson, P., Sullivan, D., Alshehry, Z., Mellett, N., Huynh, K., Simes, R., et al (2018). Large-scale plasma lipidomic profiling identifies lipids that predict cardiovascular events in secondary prevention. JCI Insight, 3(17), e121326. [More Information]
Jonker, D., Nott, L., Yoshino, T., Gill, S., Shapiro, J., Ohtsu, A., Zalcberg, J., Vickers, M., Wei, A., Gao, Y., Simes, R., et al (2018). Napabucasin versus placebo in refractory advanced colorectal cancer: a randomised phase 3 trial. The Lancet Gastroenterology & Hepatology, 3(4), 263-270. [More Information]
Mersiades, T., Tognela, A., Haber, P., Stockler, M., Lintzeris, N., Simes, R., McGregor, I., Olver, I., Allsop, D., Gedye, C., Kirby, A., Morton, R., Wong, N., Walsh, A., Grimison, P., et al (2018). Oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: a study protocol for a pilot and definitive randomised double-blind placebo-controlled trial (CannabisCINV). BMJ Open, 8(9), 1-8. [More Information]
Sjoquist, K., Renfro, L., Simes, R., Tebbutt, N., Clarke, S., Seymour, M., Adams, R., Maughan, T., Saltz, L., Goldberg, R., et al (2018). Personalizing Survival Predictions in Advanced Colorectal Cancer: The ARCAD Nomogram Project. Journal of the National Cancer Institute, 110(6), 638-648. [More Information]
Sjoquist, K., Lord, S., Friedlander, M., Simes, R., Marschner, I., Lee, C. (2018). Progression-free survival as a surrogate endpoint for overall survival in modern ovarian cancer trials: a meta-analysis. Therapeutic Advances in Medical Oncology, 10, 1-16. [More Information]
Stenson, B., Donoghoe, M., Brocklehurst, P., Davis, P., Juszczak, E., Marschner, I., Simes, R., Tarnow-Mordi, W. (2018). Pulse Oximeter Saturation Targeting and Oximeter Changes in the Benefits of Oxygen Saturation Targeting (BOOST)-II Australia and BOOST-II UK Oxygen Trials. The Journal of Pediatrics, 204, 301-304.e2. [More Information]
Herzog, S., Shanahan, M., Grimison, P., Tran, A., Wong, N., Lintzeris, N., Simes, R., Stockler, M., Morton, R. (2018). Systematic Review of the Costs and Benefits of Prescribed Cannabis-Based Medicines for the Management of Chronic Illness: Lessons from Multiple Sclerosis. PharmacoEconomics, 36(1), 67-78. [More Information]
Lee, C., Hudson, M., Simes, R., Ribi, K., Bernhard, J., Coates, A. (2018). When do patient reported quality of life indicators become prognostic in breast cancer? Health and Quality of Life Outcomes, 16(1), 13. [More Information]

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2017

Ong, K., O'Connell, R., Januszewski, A., Jenkins, A., Xu, A., Sullivan, D., Barter, P., Scott, R., Taskinen, M., Waldman, B., Simes, R., Rye, K., Keech, A., et al (2017). Baseline circulating FGF21 concentrations and increase after fenofibrate treatment predict more rapid glycemic progression in type 2 diabetes: Results from the FIELD study. Clinical Chemistry, 63(7), 1261-1270. [More Information]
Cho, D., Roncolato, F., Man, J., Simes, R., Lord, S., Links, M., Lee, C. (2017). Clinical equipoise fortrials ofnovel biologic therapies, therapeutic success rates, and predictors of success: A meta-analysis. JCO Precision Oncology, 2017 (1). [More Information]
Hovey, E., Field, K., Rosenthal, M., Barnes, E., Cher, L., Nowak, A., Wheeler, H., Sawkins, K., Livingstone (nee Ratcliffe), A., Phal, P., Simes, R., et al (2017). Continuing or ceasing bevacizumab beyond progression in recurrent glioblastoma: An exploratory randomized phase II trial. Neuro-Oncology Practice, 4(3), 171-181. [More Information]
Meikle, P., Barlow, C., Nestel, P., Barnes, E., Kirby, A., Thompson, P., Sullivan, D., Alshehry, Z., Mellett, N., Huynh, K., Simes, R., et al (2017). Decreases in plasma phosphatidylinositol species partially explain the reduction in cardiovascular events after pravastatin therapy in secondary prevention. Atherosclerosis, 263, e239. [More Information]
Tarnow-Mordi, W., Morris, J., Kirby, A., Robledo, K., Askie, L., Brown, R., Evans, N., Finlayson, S., Fogarty, M., Gebski, V., Ghadge, A., Hague, W., Isaacs, D., Jeffery, M., Keech, A., Kluckow, M., Popat, H., Sebastian, L., Liley, H., Osborn, D., Simes, R., et al (2017). Delayed versus Immediate Cord Clamping in Preterm Infants. New England Journal of Medicine, 377(25), 2445-2455. [More Information]
van den Bent, M., Gan, H., Lassman, A., Kumthekar, P., Merrell, R., Butowski, N., Lwin, Z., Mikkelsen, T., Nabors, L., Simes, R., et al (2017). Efficacy of depatuxizumab mafodotin (ABT-414) monotherapy in patients with EGFR-amplified, recurrent glioblastoma: results from a multi-center, international study. Cancer Chemotherapy and Pharmacology, 80(6), 1209-1217. [More Information]
Field, K., King, M., Simes, R., Espinoza, D., Barnes, E., Sawkins, K., Rosenthal, M., Cher, L., Hovey, E., Wheeler, H., et al (2017). Health-related quality of life outcomes from CABARET: a randomized phase 2 trial of carboplatin and bevacizumab in recurrent glioblastoma. Journal of Neuro-Oncology, 133, 623-631. [More Information]
Stewart, R., Colquhoun, D., Marschner, S., Kirby, A., Simes, R., Nestel, P., Glozier, N., O’Neil, A., Oldenburg, B., White, H., et al (2017). Persistent psychological distress and mortality in patients with stable coronary artery disease. Heart, 103(23), 1860-1866. [More Information]
Meikle, P., Mundra, P., Barlow, C., Nestel, P., Barnes, E., Kirby, A., Thompson, P., Sullivan, D., Alshehry, Z., Mellett, N., Simes, R., et al (2017). Plasma lipidomic profiles in two large independent cohorts improve upon conventional risk factors to predict cardiovascular events. Atherosclerosis, 263, e4-e5. [More Information]
Driscoll, A., Barnes, E., Blankenberg, S., Colquhoun, D., Hunt, D., Nestel, P., Stewart, R., West, M., White, H., Simes, R., et al (2017). Predictors of incident heart failure in patients after an acute coronary syndrome: The LIPID heart failure risk-prediction model. International Journal of Cardiology, 248, 361-368. [More Information]
Wetzig, N., Gill, P., Espinoza, D., Mister, R., Stockler, M., Gebski, V., Ung, O., Campbell, I., Simes, R. (2017). Sentinel-Lymph-Node-Based Management or Routine Axillary Clearance? Five-Year Outcomes of the RACS Sentinel Node Biopsy Versus Axillary Clearance (SNAC) 1 Trial: Assessment and Incidence of True Lymphedema. Annals of Surgical Oncology, 24(4), 1064-1070. [More Information]
Field, K., Phal, P., Fitt, G., Goh, C., Nowak, A., Rosenthal, M., Simes, R., Barnes, E., Sawkins, K., Cher, L., et al (2017). The role of early magnetic resonance imaging in predicting survival on bevacizumab for recurrent glioblastoma: Results from a prospective clinical trial (CABARET). Cancer, 123(18), 3576-3582. [More Information]
Leong, T., Smithers, B., Haustermans, K., Michael, M., Gebski, V., Miller, D., Zalcberg, J., Boussioutas, A., Findlay, M., O'Connell, R., Verghis, J., Simes, R., et al (2017). TOPGEAR: A Randomized, Phase III Trial of Perioperative ECF Chemotherapy with or Without Preoperative Chemoradiation for Resectable Gastric Cancer: Interim Results from an International, Intergroup Trial of the AGITG, TROG, EORTC and CCTG. Annals of Surgical Oncology, 24(8), 2252-2258. [More Information]

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2016

Liu, G., Tu, D., Lewis, M., Cheng, D., Sullivan, L., Chen, Z., Morgen, E., Simes, R., Price, T., Tebbutt, N., et al (2016). Fc-(gamma) receptor polymorphisms, cetuximab therapy, and survival in the NCIC CTG CO.17 trial of colorectal cancer. Clinical Cancer Research, 22(10), 2435-2444. [More Information]
Schofield, P., Stockler, M., Zannino, D., Tebbutt, N., Price, T., Simes, R., Wong, N., Pavlakis, N., Ransom, D., Moylan, E., Wilcken, N., et al (2016). Hope, optimism and survival in a randomised trial of chemotherapy for metastatic colorectal cancer. Supportive Care in Cancer, 24(1), 401-408. [More Information]
Collins, R., Reith, C., Emberson, J., Armitage, J., Baigent, C., Blackwell, L., Blumenthal, R., Danesh, J., Smith, G., DeMets, D., MacMahon, S., Neal, B., Rodgers, A., Simes, R., et al (2016). Interpretation of the evidence for the efficacy and safety of statin therapy. The Lancet, 388(10059), 2532-2561. [More Information]
Hague, W., Simes, R., Kirby, A., Keech, A., White, H., Hunt, D., Nestel, P., Colquhoun, D., Pater, H., Stewart, R., Sullivan, D., et al (2016). Long-Term Effectiveness and Safety of Pravastatin in Patients With Coronary Heart Disease: Sixteen Years of Follow-Up of the LIPID Study. Circulation, 133(19), 1851-1860. [More Information]
Tarnow-Mordi, W., Stenson, B., Kirby, A., Juszczak, E., Donoghoe, M., Deshpande, S., Morley, C., King, A., Doyle, L., Fleck, B., Hague, W., Gebski, V., Ghadge, A., Keech, A., Kluckow, M., Evans, N., Simes, R., et al (2016). Outcomes of two trials of oxygen-saturation targets in preterm infants. New England Journal of Medicine, 374(8), 749-760. [More Information]
Alshehry, Z., Mundra, P., Barlow, C., Mellett, N., Wong, G., McConville, M., Simes, R., Tonkin, A., Sullivan, D., Barnes, E., Neal, B., et al (2016). Plasma lipidomic profiles improve upon traditional risk factors for the prediction of cardiovascular events in Type 2 diabetes. Circulation, 134(21), 1637-1650. [More Information]
Pavlakis, N., Sjoquist, K., Martin, A., Tsobanis, E., Yip, S., Kang, Y., Bang, Y., Alcindor, T., O'Callaghan, C., Burnell, M., Wong, K., Simes, R., et al (2016). Regorafenib for the treatment of advanced gastric cancer (INTEGRATE): A multinational placebo-controlled phase II Trial. Journal of Clinical Oncology, 34(23), 2728-2735. [More Information]
Segelov, E., Thavaneswaran, S., Waring, P., Desai, J., Robledo, K., Gebski, V., Elez, E., Nott, L., Karapetis, C., Lunke, S., Pavlakis, N., Khasraw, M., Wilson, C., Simes, R., et al (2016). Response to Cetuximab With or Without Irinotecan in Patients With Refractory Metastatic Colorectal Cancer Harboring the KRAS G13D Mutation: Australasian Gastro-Intestinal Trials Group ICECREAM Study. Journal of Clinical Oncology, 34(19), 2258-2264. [More Information]
Lee, C., Davies, L., Gebski, V., Lord, S., Di Leo, A., Johnston, S., Geyer, C., Cameron, D., Press, M., Ellis, C., Marschner, I., Simes, R., et al (2016). Serum human epidermal growth factor 2 extracellular domain as a predictive biomarker for lapatinib treatment efficacy in patients with advanced breast cancer. Journal of Clinical Oncology, 34(9), 936-944. [More Information]

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2015

Lam, J., Lord, S., Hunter, K., Simes, R., Vu, T., Askie, L. (2015). Australian clinical trial activity and burden of disease: an analysis of registered trials in National Health Priority Areas. Medical Journal of Australia, 203(2), 97-102. [More Information]
Tonkin, A., Blankenberg, S., Kirby, A., Zeller, T., Colquhoun, D., Funke-Kaiser, A., Hague, W., Hunt, D., Keech, A., Nestel, P., Sullivan, D., Simes, R., et al (2015). Biomarkers in stable coronary heart disease, their modulation and cardiovascular risk: The LIPID biomarker study. International Journal of Cardiology, 201, 499-507. [More Information]
Price, T., Bruhn, M., Lee, C., Hardingham, J., Townsend, A., Robledo, K., Simes, R., Weickhardt, A., Wrin, J., Wilson, C., Gebski, V., et al (2015). Correlation of extended RAS and PIK3CA gene mutation status with outcomes from the phase III AGITG MAX STUDY involving capecitabine alone or in combination with bevacizumab plus or minus mitomycin C in advanced colorectal cancer. British Journal of Cancer, 112(6), 963-970. [More Information]
Stevenson, A., Solomon, M., Lumley, J., Hewett, P., Clouston, A., Gebski, V., Davies, L., Wilson, C., Hague, W., Simes, R. (2015). Effect of laparoscopic-assisted resection vs open resection on pathological outcomes in rectal cancer: The ALaCaRT randomized clinical trial. JAMA - Journal of the American Medical Association, 314(13), 1356-1363. [More Information]
Fulcher, J., O'Connell, R., Voysey, M., Emberson, J., Blackwell, L., Mihaylova, B., Simes, J., Collins, R., Kirby, A., Colhoun, H., Keech, A., et al (2015). Efficacy and safety of LDL-lowering therapy among men and women: Meta-analysis of individual data from 174 000 participants in 27 randomised trials. The Lancet, 385(9976), 1397-1405. [More Information]
Whittle, J., Lickliter, J., Gan, H., Scott, A., Simes, R., Solomon, B., MacDiarmid, J., Brahmbhatt, H., Rosenthal, M. (2015). First in human nanotechnology doxorubicin delivery system to target epidermal growth factor receptors in recurrent glioblastoma. Journal of Clinical Neuroscience, 22(12), 1889-1894. [More Information]
Elmadahm, A., Gill, P., Bochner, M., Gebski, V., Zannino, D., Wetzig, N., Campbell, I., Stockler, M., Ung, O., Simes, R., Uren, R. (2015). Identification of the sentinel lymph node in the SNAC-1 trial. ANZ Journal of Surgery, 85(1-2), 58-63. [More Information]
Chandrasegaram, M., Goldstein, D., Simes, R., Gebski, V., Kench, J., Gill, A., Samra, J., Merrett, N., Richardson, A., Barbour, A. (2015). Meta-analysis of radical resection rates and margin assessment in pancreatic cancer. British Journal of Surgery, 102(12), 1459-1472. [More Information]
Chantrill, L., Nagrial, A., Watson, C., Johns, A., Martyn-Smith, M., Simpson, S., Mead, S., Jones, M., Samra, J., Gill, A., Chin, V., Sebastian, L., Sjoquist, K., Yip, S., Pavlakis, N., Grimison, P., Simes, R., et al (2015). Precision Medicine for Advanced Pancreas Cancer: The Individualized Molecular Pancreatic Cancer Therapy (IMPaCT) Trial. Clinical Cancer Research, 21(9), 2029-2037. [More Information]
Field, K., Simes, J., Nowak, A., Cher, L., Wheeler, H., Hovey, E., Brown, C., Barnes, E., Sawkins, K., Livingstone (nee Ratcliffe), A., et al (2015). Randomized phase 2 study of carboplatin and bevacizumab in recurrent glioblastoma. Neuro-Oncology, 17(11), 1504-1513. [More Information]
Wetzig, N., Gill, P., Zannino, D., Stockler, M., Gebski, V., Ung, O., Campbell, I., Simes, R. (2015). Sentinel Lymph Node Based Management or Routine Axillary Clearance? Three-year Outcomes of the RACS Sentinel Node Biopsy Versus Axillary Clearance (SNAC) 1 Trial. Annals of Surgical Oncology, 22(1), 17-23. [More Information]
Ghersi, D., Willson, M., Chan, M., Simes, R., Donoghue, E., Wilcken, N. (2015). Taxane-containing regimens for metastatic breast cancer. Cochrane Database of Systematic Reviews, 6, 1-170. [More Information]
Leong, T., Smithers, B., Michael, M., Gebski, V., Boussioutas, A., Miller, D., Simes, R., Zalcberg, J., Haustermans, K., Lordick, F., et al (2015). TOPGEAR: A randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric cancer (an international, intergroup trial of the AGITG/TROG/EORTC/NCIC CTG). BMC Cancer, 15(1), 1-6. [More Information]
Weickhardt, A., Williams, D., Lee, C., Chionh, F., Simes, R., Murone, C., Byth Wilson, K., Parry, M., Asadi, K., Scott, A., et al (2015). Vascular endothelial growth factor D expression is a potential biomarker of bevacizumab benefit in colorectal cancer. British Journal of Cancer, 113(1), 37-45. [More Information]

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2014

Simes, R., Becattini, C., Agnelli, G., Eikelboom, J., Kirby, A., Mister, R., Prandoni, P., Brighton, T. (2014). Aspirin for the Prevention of Recurrent Venous Thromboembolism: The INSPIRE Collaboration. Circulation, 130(13), 1062-1071. [More Information]
White, H., Tonkin, A., Simes, R., Stewart, R., Robledo, K., Thompson, P., Colquhoun, D., West, M., Nestel, P., Sullivan, D., Keech, A., et al (2014). Association of Contemporary Sensitive Troponin I Levels at Baseline and Change at 1 Year With Long - Term Coronary Events Following Myocardial Infarction or Unstable Angina. Journal of the American College of Cardiology, 63(4), 345-354. [More Information]
Jonker, D., Karapetis, C., Harbison, C., Oâ€™Callaghan, C., Tu, D., Simes, R., Malone, D., Langer, C., Tebbutt, N., Price, T., et al (2014). Epiregulin gene expression as a biomarker of benefit from cetuximab in the treatment of advanced colorectal cancer. British Journal of Cancer, 110(3), 648-655. [More Information]
Ransom, D., Wilson, C., Fournier, M., Simes, R., Gebski, V., Yip, D., Tebbutt, N., Karapetis, C., Ferry, D., Gordon, S., et al (2014). Final results of Australasian Gastrointestinal Trials Group ARCTIC study: An audit of raltitrexed for patients with cardiac toxicity induced by fluoropyrimidines. Annals of Oncology, 25(1), 117-121. [More Information]
Mcgrath, P., Ghersi, D., Simes, R., Wilcken, N. (2014). Larger versus smaller dose of the same drug/s regimen for metastatic breast cancer. Cochrane Database of Systematic Reviews, 2014 (5). [More Information]
Funke-Kaiser, A., Robledo, K., Colquhoun, D., Zeller, T., Hunt, D., Simes, R., Sullivan, D., Sydow, K., West, M., White, H., et al (2014). Midregional proadrenomedullin and its change predicts recurrent major coronary events and heart failure in stable coronary heart disease patients: the LIPID study. International Journal of Cardiology, 172(2), 411-418. [More Information]
Chen, J., Hovey, E., Rosenthal, M., Livingstone (nee Ratcliffe), A., Simes, R. (2014). Neuro-oncology practices in Australia: A Cooperative Group for Neuro-Oncology patterns of care study. Asia-Pacific Journal of Clinical Oncology, 10(2), 162-167. [More Information]
Karapetis, C., Jonker, D., Daneshmand, M., Hanson, J., O'Callghan, C., Marginean, C., Zalcberg, J., Simes, R., Moore, M., Tebbutt, N., et al (2014). PIK3CA, BRAF, and PTEN Status and Benefit from Cetuximab in the Treatment of Advanced Colorectal Cancer--Results from NCIC CTG/AGITG CO.17. Clinical Cancer Research, 20(3), 744-753. [More Information]
White, H., Tonkin, A., Simes, R., Stewart, R., Robledo, K. (2014). Reply to Letter to the Editor: Troponin I to target treatments which reduce cardiovascular risk - while waiting for Godot. Journal of the American College of Cardiology, 636(25), 2876-2886.
Hudson, H., Lo, S., Simes, R., Tonkin, A., Heritier, S. (2014). Semiparametric methods for multistate survival models in randomised trials. Statistics in Medicine, 33, 1621-1645. [More Information]
Carter, H., Zannino, D., Simes, R., Schofield, D., Howard, K., Zalcberg, J., Price, T., Tebbutt, N. (2014). The cost effectiveness of bevacizumab when added to capecitabine, with or without mitomycin-C, in first line treatment of metastatic colorectal cancer: Results from the Australasian phase III MAX study. European Journal of Cancer, 50(3), 535-543. [More Information]
Sommeijer, D., Karapetis, C., Zalcberg, J., Tu, D., Jonker, D., Simes, R., Tebbutt, N., Yip, D., Price, T., Oâ€™CALLAGHAN, C. (2014). The relationship between rash, tumour KRAS mutation status and clinical and quality of life outcomes in patients with advanced colorectal cancer treated with cetuximab in the NCIC CTG/AGITG CO.17. Acta Oncologica, 53(7), 877-884. [More Information]
Boekholdt, S., Hovingh, G., Mora, S., Arsenault, B., Amarenco, P., Pedersen, T., LaRosa, J., Waters, D., DeMicco, D., Simes, R., Keech, A., et al (2014). Very low levels of atherogenic lipoproteins and the risk for cardiovascular events: a meta-analysis of statin trials. Journal of the American College of Cardiology, 64(5), 485-494. [More Information]
Glasziou, P., Irwig, L., Kirby, A., Tonkin, A., Simes, R. (2014). Which lipid measurement should we monitor? An analysis of the LIPID study. BMJ Open, 4(2), 1-6. [More Information]

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2013

Simes, R., Winship, I., McNeil, J. (2013). A funding model for public-good clinical trials. Medical Journal of Australia, 199(2), 90-91. [More Information]
Lee, C., Simes, R., Brown, C., Gebski, V., Pfisterer, J., Swart, A., Berton-Rigaud, D., Plante, M., Skeie-Jensen, T., Vergote, I., Lord, S., et al (2013). A prognostic nomogram to predict overall survival in patients with platinum-sensitive recurrent ovarian cancer. Annals of Oncology, 24(4), 937-943. [More Information]
Simes, R., Eikelboom, J., Brighton, T. (2013). Aspirin for preventing venous thromboembolism. New England Journal of Medicine, 368(8), 773. [More Information]
Vickers, M., Karapetis, C., Tu, D., O'Callaghan, C., Price, T., Tebbutt, N., van Hazel, G., Shapiro, J., Pavlakis, N., Gibbs, P., Simes, R., et al (2013). Association of hypomagnesemia with inferior survival in a phase III, randomized study of cetuximab plus best supportive care versus best supportive care alone: NCIC CTG/AGITG CO.17. Annals of Oncology, 24(4), 953-960. [More Information]
White, H., Simes, R., Stewart, R., Blankenberg, S., Barnes, E., Marschner, I., Thompson, P., West, M., Zeller, T., Colquhoun, D., Keech, A., Sullivan, D., et al (2013). Changes in lipoprotein-associated phospholipase A2 activity predict coronary events and partly account for the treatment effect of pravastatin: results from the Long-Term Intervention with Pravastatin in Ischemic Disease study. Journal of the American Heart Association, 2(5), 1-12. [More Information]
Stenson, B., Tarnow-Mordi, W., Darlow, B., Simes, R., Juszczak, E., Askie, L., Battin, M., Bowler, U., Broadbent, R., Cairns, P., Donoghoe, M., Ghadge, A., Hague, W., Kirby, A., et al (2013). Oxygen Saturation and Outcomes in Preterm Infants. New England Journal of Medicine, 368(22), 2094-2104. [More Information]
Siu, L., Shapiro, J., Jonker, D., Karapetis, C., Zalcberg, J., Simes, R., Couture, F., Moore, M., Price, T., Siddiqui, J., et al (2013). Phase III Randomized, Placebo-Controlled Study of Cetuximab Plus Brivanib Alaninate Versus Cetuximab Plus Placebo in PatientsWith Metastatic, Chemotherapy-Refractory, Wild-TypeK-RASColorectal Carcinoma: The NCIC Clinical Trials Group and AGITG CO.20 Trial. Journal of Clinical Oncology, 31(19), 2477-2484. [More Information]
Nestel, P., Barnes, E., Tonkin, A., Simes, R., Fournier, M., White, H., Colquhoun, D., Blankenberg, S., Sullivan, D. (2013). Plasma Lipoprotein(a) Concentration Predicts Future Coronary and Cardiovascular Events in Patients With Stable Coronary Heart Disease. Arteriosclerosis, Thrombosis, and Vascular Biology, 33(12), 2902-2908. [More Information]
Price, T., Hardingham, J., Lee, C., Townsend, A., Wrin, J., Wilson, K., Weickhardt, A., Simes, R., Murone, C., Tebbutt, N. (2013). Prognostic impact and the relevance of PTEN copy number alterations in patients with advanced colorectal cancer (CRC) receiving bevacizumab. Cancer Medicine, 2(3), 277-285. [More Information]
Martin, A., Simes, R. (2013). Quality-adjusted survival as an end point in breast cancer trials. Clinical Investigation, 3(6), 545-555. [More Information]
Anderson, C., Heeley, E., Huang, Y., Wang, J., Stapf, C., Delcourt, C., Lindley, R., Robinson, T., Lavados, P., Neal, B., Hata, J., Arima, H., Heritier, S., Li, Q., Woodward, M., Simes, R., Chalmers, J., et al (2013). Rapid Blood-Pressure Lowering in Patients with Acute Intracerebral Hemorrhage. New England Journal of Medicine, 368(25), 2355-2365. [More Information]
Tarnow-Mordi, W., Simes, R., Cruz, M. (2013). Strategies to accelerate recruitment to NHMRC multi-centre clinical trials. Journal of Paediatrics and Child Health, 49(1), e103-e105. [More Information]
Simes, R., Webb, S. (2013). Sustaining Australian research through clinical trials and investigator networks. Medical Journal of Australia, 198(3), 127-128. [More Information]
Lee, C., Gebski, V., Coates, A., Veillard, A., Harvey, V., Tattersall, M., Byrne, M., Brigham, B., Forbes, J., Simes, R. (2013). Trade-offs in quality of life and survival with chemotherapy for advanced breast cancer: mature results of a randomized trial comparing single-agent mitoxantrone with combination cyclophosphamide, methotrexate, 5-fluorouracil and prednisone. SpringerPlus, 2(391), 1-10. [More Information]

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2012

Boekholdt, S., Arsenault, B., Mora, S., Pedersen, T., LaRosa, J., Nestel, P., Simes, R., Durrington, P., Hitman, G., Welch, K., et al (2012). Association of LDL cholesterol, non-HDL cholesterol, and apolipoprotein B levels with risk of cardiovascular events among patients treated with statins: a meta-analysis. JAMA - Journal of the American Medical Association, 307(12), 1302-1309. [More Information]
Ting, R., Keech, A., Drury, P., Donoghoe, M., Hedley, J., Jenkins, A., Davis, T., Lehto, S., Celermajer, D., Simes, R., Rajamani, K., et al (2012). Benefits and Safety of Long-Term Fenofibrate Therapy in People With Type 2 Diabetes and Renal Impairment - The FIELD Study. Diabetes Care, 35(2), 218-225. [More Information]
Price, T., Zannino, D., Wilson, C., Simes, R., Cassidy, J., Van Hazel, G., Robinson, B., Broad, A., Ganju, V., Ackland, S., Tebbutt, N. (2012). Bevacizumab is equally effective and no more toxic in elderly patients with advanced colorectal cancer: a subgroup analysis from the AGITG MAX trial: an international randomised controlled trial of Capecitabine, Bevacizumab and Mitomycin C. Annals of Oncology, 23(6), 1531-1536. [More Information]
Carter, H., Lord, S., Martin, A., Gill, G., Lee, C., Howard, K., Wetzig, N., Simes, R. (2012). Effectiveness and cost-effectiveness of sentinel lymph node biopsy compared with axillary node dissection in patients with early-stage breast cancer: a decision model analysis. British Journal of Cancer, 106(6), 1045-1052. [More Information]
Tonkin, A., Hunt, D., Voysey, M., Kesaniemi, Y., Hamer, A., Waites, J., Mahar, L., Mann, S., Glasziou, P., Forder, P., Simes, R., Keech, A. (2012). Effects of fenofibrate on cardiovascular events in patients with diabetes, with and without prior cardiovascular disease: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. American Heart Journal, 163(3), 508-514. [More Information]
Dear, R., Barratt, A., Evans, A., Simes, R., Newsom, J., Kent, D., Crossing, S., Holliday, C., Segelov, E., Hruby, G., Tattersall, M. (2012). Identifying and prioritising gaps in colorectal cancer trials research in Australia. Medical Journal of Australia, 197(9), 507-511. [More Information]
Lee, C., Marschner, I., Simes, R., Voysey, M., Egleston, B., Hudes, G., de Souza, P. (2012). Increase in Cholesterol PredictsSsurvival Advantage in Renal Cell Carcinoma Patients Treated with Temsirolimus. Clinical Cancer Research, 18(11), 3188-3196. [More Information]
Emberson, J., Kearney, P., Blackwell, L., Newman, C., Reith, C., Bhala, N., Holland, L., Peto, R., Keech, A., Collins, R., Simes, R., et al (2012). Lack of effect of lowering LDL cholesterol on cancer: meta-analysis of individual data from 175 000 people in 27 randomised trials of statin therapy. PloS One, 7(1), 1-10. [More Information]
Staub, L., Dyer, S., Lord, S., Simes, R. (2012). Linking the evidence: intermediate outcomes in medical test assessments. International Journal of Technology Assessment in Health Care, 28(1), 52-58. [More Information]
Brighton, T., Eikelboom, J., Robledo, K., Mister, R., Gallus, A., Ockelford, P., Gibbs, H., Hague, W., Xavier, D., Diaz, R., Kirby, A., Simes, R. (2012). Low-Dose Aspirin for Preventing Recurrent Venous Thromboembolism. New England Journal of Medicine, 367(2), 1979-1987. [More Information]
Mihaylova, B., Emberson, J., Blackwell, L., Keech, A., Simes, R., Barnes, E., Voysey, M., Gray, A., Collins, R., Baigent, C., et al (2012). The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. The Lancet, 380(9841), 581-590. [More Information]
Keech, A., Simes, R., Fulcher, J. (2012). The role of statin therapy in patients with lower vascular risk. Medical Journal of Australia, 197(3), 130-131. [More Information]
Staub, L., Lord, S., Simes, R., Dyer, S., Houssami, N., Chen, R., Irwig, L. (2012). Using patient management as a surrogate for patient health outcomes in diagnostic test evaluation. BMC Medical Research Methodology, 12, 1-12. [More Information]

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2011

Lee, C., Hudson, M., Stockler, M., Coates, A., Ackland, S., Gebski, V., Lord, S., Friedlander, M., Boyle, F., Simes, R. (2011). A nomogram to predict survival time in women starting first-line chemotherapy for advanced breast cancer. Breast Cancer Research and Treatment, 129(2), 467-476. [More Information]
Sullivan, D., Forder, P., Simes, R., Whiting, M., Kritharides, L., Merrifield, A., Donoghoe, M., Colman, P., Neil, G., Haapamaki, H., Keech, A. (2011). Associations between the use of metformin, sulphonylureas, or diet alone and cardiovascular outcomes in 6005 patients with type 2 diabetes in the FIELD study. Diabetes Research and Clinical Practice, 94(2), 284-290. [More Information]
Stockler, M., Harvey, V., Francis, P., Byrne, M., Ackland, S., Fitzharris, B., Van Hazel, G., Wilcken, N., Grimison, P., Nowak, A., Zannino, D., Gebski, V., Coates, A., et al (2011). Capecitabine Versus Classical Cyclophosphamide, Methotrexate, and Fluorouracil As First-Line Chemotherapy for Advanced Breast Cancer. Journal of Clinical Oncology, 29(34), 4498-4504. [More Information]
Lee, C., Gurney, H., Brown, C., Sorio, R., Donadello, N., Tulunay, G., Meier, W., Bacon, M., Maenpaa, J., Petru, E., Gebski, V., Lord, S., Simes, R., et al (2011). Carboplatin-paclitaxel-induced leukopenia and neuropathy predict progression-free survival in recurrent ovarian cancer. British Journal of Cancer, 105(3), 360-365. [More Information]
Lee, C., Friedlander, M., Brown, C., Gebski, V., Georgoulopoulos, A., Vergote, I., Pignata, S., Donadello, N., Schmalfeldt, B., Delva, R., Lord, S., Simes, R., et al (2011). Early Decline in Cancer Antigen 125 as a Surrogate for Progression-Free Survival in Recurrent Ovarian Cancer. Journal of the National Cancer Institute, 103(17), 1338-1342. [More Information]
Davis, T., Ting, R., Best, J., Donoghoe, M., Drury, P., Sullivan, D., Jenkins, A., O'Connell, R., Whiting, M., Glasziou, P., Simes, R., Gebski, V., Keech, A., et al (2011). Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia, 54(2), 280-290. [More Information]
Goel, S., Simes, R., Beith, J. (2011). Exploratory analysis of cardiac biomarkers in women with normal cardiac function receiving trastuzumab for breast cancer. Asia-Pacific Journal of Clinical Oncology, 7(3), 276-280. [More Information]
de Boer, S., Barnes, E., Westerhout, C., Simes, J., Granger, C., Kastrati, A., Widimsky, P., de Boer, M., Zijlstra, F., Boersma, E. (2011). High-risk patients with ST-elevation myocardial infarction derive greatest absolute benefit from primary percutaneous coronary intervention: Results from the Primary Coronary Angioplasty Trialist versus Thrombolysis (PCAT)-2 Collaboration. American Heart Journal, 161(3), 500-507.e1. [More Information]
Dear, R., Barratt, A., McGeechan, K., Askie, L., Simes, R., Tattersall, M. (2011). Landscape of cancer clinical trials in Australia: using trial registries to guide future research. Medical Journal of Australia, 194(8), 387-391. [More Information]
Simes, R. (2011). Medical Oncology Group of Australia Cancer Achievement Award - Inspirations and influences for a life in clinical trials. Cancer Forum, 35(1), 48-50.
Ananda, S., Nowak, A., Cher, L., Dowling, A., Brown, C., Simes, R., Rosenthal, M. (2011). Phase 2 trial of temozolomide and pegylated liposomal doxorubicin in the treatment of patients with glioblastoma multiforme following concurrent radiotherapy and chemotherapy. Journal of Clinical Neuroscience, 18(11), 1444-1448. [More Information]
Lee, C., Simes, R., Brown, C., Lord, S., Wagner, U., Plante, M., Vergote, I., Pisano, C., Parma, G., Burges, A., Gebski, V., et al (2011). Prognostic nomogram to predict progression-free survival in patients with platinum-sensitive recurrent ovarian cancer. British Journal of Cancer, 105(8), 1144-1150. [More Information]
Cox, K., Goel, S., O'Connell, R., Boyer, M., Beale, P., Simes, R., Stockler, M. (2011). Randomized cross-over trial comparing inpatient and outpatient administration of high-dose cisplatin. Internal Medicine Journal, 41(2), 172-178. [More Information]
Tebbutt, N., Murphy, F., Zannino, D., Wilson, C., Parry, M., Abdi, E., Strickland, A., Lowenthal, R., Marx, G., Karapetis, C., Shannon, J., Simes, R., et al (2011). Risk of arterial thromboembolic events in patients with advanced colorectal cancer receiving bevacizumab. Annals of Oncology, 22(8), 1834-1838. [More Information]
Farrar, D., Duley, L., Burls, A., Dorling, J., Embleton, N., McGuire, W., Oddie, S., Simes, R., Tarnow-Mordi, W., Thornton, J., et al (2011). Rushing to clamp umbilical cord: More evidence is needed to inform practice. BMJ: British Medical Journal, 342(Letters), d122-d122. [More Information]
Clarke, S., Yip, S., Brown, C., van Hazel, G., Ransom, D., Goldstein, D., Jeffrey, G., Tebbutt, N., Buck, M., Lowenthal, R., Boland, A., Gebski, V., Simes, R., et al (2011). Single-agent irinotecan or 5-fluorouracil and leucovorin (FOLFIRI) as second-line chemotherapy for advanced colorectal cancer; results of a randomised phase II study (DaVINCI) and meta-analysis. European Journal of Cancer, 47(12), 1826-1836. [More Information]
Sjoquist, K., Burmeister, B., Smithers, B., Zalcberg, J., Simes, R., Barbour, A., Gebski, V. (2011). Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. The Lancet Oncology, 12(7), 681-692. [More Information]

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2010

Simes, R., Voysey, M., O'Connell, R., Glasziou, P., Best, J., Scott, R., Pardy, C., Byth Wilson, K., Sullivan, D., Ehnholm, C., Keech, A. (2010). A novel method to adjust efficacy estimates for uptake of other active treatments in long-term clinical trials. PloS One, 5(1), e8580-1-e8580-10. [More Information]
Taskinen, M., Barter, P., Ehnholm, C., Sullivan, D., Robledo, K., Simes, R., Best, J., Hamwood, S., Keech, A. (2010). Ability of traditional lipid ratios and apolipoprotein ratios to predict cardiovascular risk in people with type 2 diabetes. Diabetologia, 53(9), 1846-1855. [More Information]
De Roock, W., Jonker, D., Di Nicolantonio, F., Sartore-Bianchi, A., Tu, D., Siena, S., Lamba, S., Arena, S., Frattini, M., Piessevaux, H., Simes, R., et al (2010). Association of KRAS p.G13D Mutation With Outcome in Patients With Chemotherapy-Refractory Metastatic Colorectal Cancer Treated With Cetuximab. JAMA - Journal of the American Medical Association, 304(16), 1812-1820. [More Information]
Tebbutt, N., Wilson, K., Gebski, V., Cummins, M., Zannino, D., van Hazel, G., Robinson, B., Broad, A., Ganju, V., Ackland, S., Stockler, M., Simes, R., et al (2010). Capecitabine, Bevacizumab and Mitomycin in First-Line Treatment of Metastatic Colorectal Cancer: Results of the Australasian Gastrointestinal Trials Group Randomized, Phase III MAX Study. Journal of Clinical Oncology, 28(19), 3191-3198. [More Information]
Van Glabbeke, M., Verweij, J., Blay, J., Debiec-Rychter, M., Demetri, G., Heinrich, M., Borden, E., Blanke, C., Crowley, J., Rankin, C., Zalcberg, J., Simes, R., et al (2010). Comparison of Two Doses of Imatinib for the Treatment of Unresectable or Metastatic Gastrointestinal Stromal Tumors: A Meta-Analysis of 1,640 Patients. Journal of Clinical Oncology, 28(7), 1247-1253. [More Information]
Grimison, P., Stockler, M., Thomson, D., Olver, I., Harvey, V., Gebski, V., Lewis, C., Levi, J., Boyer, M., Gurney, H., Boland, A., Simes, R., et al (2010). Comparison of Two Standard Chemotherapy Regimens for Good-Prognosis Germ Cell Tumors: Updated Analysis of a Randomized Trial. Journal of the National Cancer Institute, 102(16), 1253-1262. [More Information]
Davis, T., Ting, R., Best, J., Donoghoe, M., Drury, P., Sullivan, D., Jenkins, A., O'Connell, R., Whiting, M., Glasziou, P., Simes, R., Gebski, V., Keech, A., et al (2010). Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. Diabetologia, 54(2), 280-290. [More Information]
Baigent, C., Blackwell, L., Emberson, J., Holland, L., Reith, C., Bhala, N., Peto, R., Barnes, E., Keech, A., Simes, R., et al (2010). Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised trials. The Lancet, 376(9753), 1670-1681. [More Information]
Lee, C., Lord, S., Stockler, M., Coates, A., Gebski, V., Simes, R. (2010). Historical cross-trial comparisons for competing treatments in advanced breast cancer - An empirical analysis of bias. European Journal of Cancer, 46(3), 541-548. [More Information]
de Boer, S., Westerhout, C., Simes, R., Granger, C., Zijlstra, F., Boersma, E. (2010). Mortality and Morbidity Reduction by Primary Percutaneous Coronary Intervention Is Independent of the Patient's Age. J A C C: Cardiovascular Interventions, 3(3), 324-331. [More Information]
Lee, C., Stockler, M., Coates, A., Gebski, V., Lord, S., Simes, R. (2010). Self-reported health-related quality of life is an independent predictor of chemotherapy treatment benefit and toxicity in women with advanced breast cancer. British Journal of Cancer, 102(9), 1341-1347. [More Information]
Cui, J., Forbes, A., Kirby, A., Marschner, I., Simes, R., Hunt, D., West, M., Tonkin, A. (2010). Semi-parametric risk prediction models for recurrent cardiovascular events in the LIPID study. BMC Medical Research Methodology, 10(27), 27-1-27-9. [More Information]
Askie, L., Baur, L., Campbell, K., Daniels, L., Hesketh, K., Magarey, A., Mihrshahi, S., Rissel, C., Simes, R., Taylor, B., Voysey, M., et al (2010). The Early Prevention of Obesity in CHildren (EPOCH) Collaboration - an Individual Patient Data Prospective Meta-Analysis. BMC Public Health, 10, 728-1-728-8. [More Information]
Califf, R., Armstrong, P., Granger, C., Harrington, R., Lee, K., Simes, R., van de Werf, F., Wallentin, L., White, H. (2010). Towards a new order in cardiovascular medicine: re-engineering through global collaboration. European Heart Journal, 31(8), 911-917. [More Information]
Simes, R., O'Connell, R., Aylward, P., Varshavsky, S., Diaz, R., Wilcox, R., Armstrong, P., Granger, C., French, J., Van de Werf, F., Marschner, I., et al (2010). Unexplained international differences in clinical outcomes after acute myocardial infarction and fibrinolytic therapy: Lessons from the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. American Heart Journal, 159(6), 988-997. [More Information]

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2009

Grimison, P., Simes, R., Hudson, M., Stockler, M. (2009). Deriving a Patient-Based Utility Index from a Cancer-Specific Quality of Life Questionnaire. Value in Health, 12(5), 800-807. [More Information]
Cui, J., Forbes, A., Kirby, A., Simes, R., Tonkin, A. (2009). Laboratory and non-laboratory-based risk prediction models for secondary prevention of cardiovascular disease: the LIPID study. European Journal of Cardiovascular Prevention and Rehabilitation, 16(6), 660-668. [More Information]
Soderberg, S., Colquhoun, D., Keech, A., Yallop, J., Barnes, E., Pollicino, C., Simes, R., Tonkin, A., Nestel, P. (2009). Leptin, but not adiponectin, is a predictor of recurrent cardiovascular events in men: results from the LIPID study. International Journal of Obesity, 33(1), 123-130. [More Information]
Lee, C., Lord, S., Coates, A., Simes, R. (2009). Molecular biomarkers to individualise treatment: assessing the evidence. Medical Journal of Australia, 190(11), 631-636. [More Information]
Grimison, P., Simes, R., Hudson, M., Stockler, M. (2009). Preliminary Validation of an Optimally Weighted Patient-Based Utility Index by Application to Randomized Trials in Breast Cancer. Value in Health, 12(6), 967-976. [More Information]
Mittman, N., Au, H., Tu, D., O'Callaghan, C., Isogai, P., Karapetis, C., Zalcberg, J., Evans, W., Moore, M., Siddiqui, J., Simes, R., Tebbutt, N., et al (2009). Prospective Cost-Effectiveness Analysis of Cetuximab in Metastatic Colorectal Cancer: Evaluation of National Cancer Institute of Canada Clinical Trials Group CO.17 Trial. Journal of the National Cancer Institute, 101(17), 1182-1192. [More Information]
Taskinen, M., Sullivan, D., Ehnholm, C., Whiting, M., Zannino, D., Simes, R., Keech, A., Barter, P. (2009). Relationships of HDL cholesterol, ApoA-I, and ApoA-II with homocysteine and creatinine in patients with Type 2 diabetes treated with fenofibrate. Arteriosclerosis, Thrombosis, and Vascular Biology, 29(6), 950-955. [More Information]
Gill, G., Wetzig, N., Gebski, V., Stockler, M., Ung, O., Campbell, I., Simes, R. (2009). Sentinel-Lymph-Node-Based Management or Routine Axillary Clearance? One-Year Outcomes of Sentinel Node Biopsy Versus Axillary Clearance (SNAC): A Randomized Controlled Surgical Trial. Annals of Surgical Oncology, 16(2), 266-275. [More Information]
Berger, J., Elliott, L., Gallup, D., Roe, M., Granger, C., Armstrong, P., Simes, R., White, H., Van de Werf, F., Topol, E., et al (2009). Sex Differences in Mortality Following Acute Coronary Syndromes. JAMA - Journal of the American Medical Association, 302(8), 874-882. [More Information]
Carrick, S., Parker, S., Thornton, C., Ghersi, D., Simes, R., Wilcken, N. (2009). Single agent versus combination chemotherapy for metastatic breast cancer. Cochrane Database of Systematic Reviews, (2), CD003372-1-CD003372-109. [More Information]
Clarke, P., Hayes, A., Glasziou, P., Scott, R., Simes, R., Keech, A. (2009). Using the EQ-5D index score as a predictor of outcomes in patients with type 2 diabetes. Medical Care, 47(1), 61-68. [More Information]

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2008

Hayes, A., Clarke, P., Glasziou, P., Simes, R., Drury, P., Keech, A. (2008). Can self-rated health scores be used for risk prediction in patients with type 2 diabetes? Diabetes Care, 31(4), 795-797. [More Information]
Smith, M., Gill, P., Wetzig, N., Sourjina, T., Gebski, V., Ung, O., Campbell, I., Kollias, J., Coskinas, X., Macphee, A., Simes, R., Stockler, M., et al (2008). Comparing patients' and clinicians' assessment of outcomes in a randomised trial of sentinel node biopsy for breast cancer (the RACS SNAC trial). Breast Cancer Research and Treatment, 117(1), 99-109. [More Information]
Duric, V., Butow, P., Sharpe, L., Heritier, S., Boyle, F., Beith, J., Wilcken, N., Coates, A., Simes, R., Stockler, M. (2008). Comparing patients' and their partners' preferences for adjuvant chemotherapy in early breast cancer. Patient Education and Counseling, 72(2), 239-245. [More Information]
Stewart, R., North, F., Sharples, K., Simes, R., Tonkin, A., White, H. (2008). Differences in cardiovascular mortality between Australia and New Zealand according to socioeconomic status: findings from the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study. New Zealand Medical Journal, 121(1269), 11-23.
Kearney, P., Blackwell, L., Collins, R., Keech, A., Simes, R., Peto, R., Armitage, J., Baigent, C. (2008). Efficacy of cholesterol-lowering therapy in 18 686 people with diabetes in 14 randomised trials of statins: a meta-analysis. The Lancet, 371, 117-125. [More Information]
Keech, A., Mitchell, P., Summanen, P., Davis, T., Simes, R. (2008). Fenofibrate and diabetic retinopathy - Authors' reply. The Lancet, 371(9614), 722-722. [More Information]
Berger, J., Stebbins, A., Granger, C., Ohman, E., Armstrong, P., Van de Werf, F., White, H., Simes, R., Harrington, R., Califf, R., et al (2008). Initial Aspirin Dose and Outcome Among ST-Elevation Myocardial Infarction Patients Treated With Fibrinolytic Therapy. Circulation, 117(2), 192-199. [More Information]
Karapetis, C., Khambata-Ford, S., Jonker, D., O'Callaghan, C., Tu, D., Tebbutt, N., Simes, R., Chalchal, H., Shapiro, J., Robitaille, S., et al (2008). K-ras Mutations and Benefit from Cetuximab in Advanced Colorectal Cancer. New England Journal of Medicine, 359(17), 1757-1765. [More Information]
Glasziou, P., Irwig, L., Heritier, S., Simes, R., Tonkin, A. (2008). Monitoring cholesterol levels: Measurement error or true change? Annals of Internal Medicine, 148(9), 656-661. [More Information]
Cui, J., Forbes, A., Kirby, A., Marschner, I., Simes, R., West, M., Tonkin, A. (2008). Parametric conditional frailty models for recurrent cardiovascular events in the lipid study. Clinical Trials, 5(6), 565-574. [More Information]
Kearney, P., Keech, A., Simes, R., Collins, R. (2008). Statins and diabetes: authors' reply. The Lancet, 371(9626), 1752-1752.
Dwan, K., Altman, D., Arnaiz, J., Bloom, J., Chan, A., Cronin, E., Decullier, E., Easterbrook, P., Von Elm, E., Gamble, C., Ghersi, D., Simes, R., et al (2008). Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias. PloS One, 3(8), e3081-1-e3081-31. [More Information]
Lord, S., Lee, C., Simes, R. (2008). The Role of Predictive and Prognostic Markers in Cancer. Cancer Forum, 32(3), 139-142.
West, M., Nestel, P., Kirby, A., Schnabel, R., Sullivan, D., Simes, R., Pollicino, C., Lubos, E., Munzel, T., White, H., et al (2008). The value of N-terminal fragment of brain natriuretic peptide and tissue inhibitor of metalloproteinase-1 levels as predictors of cardiovascular outcome in the LIPID study. European Heart Journal, 29(7), 923-931. [More Information]

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2007

Lord, S., Irwig, L., Simes, R. (2007). A philosophical approach to diagnostic test evaluation - In Response. Annals of Internal Medicine, 146(10), 757-758.
Gebski, V., Keech, A., Simes, R. (2007). Applying subgroup analysis to individual patient decisions. In Anthony Keech, Val Gebski, Rhana Pike (Eds.), Interpreting and reporting clinical trials: a guide to the CONSORT statement and the principles of randomised controlled trials, (pp. 114-122). Sydney: AMPCo.
Marschner, I., Simes, R., Keech, A. (2007). Biases in the Identification of Risk Factor Thresholds and J-Curves. American Journal of Epidemiology, 166(7), 824-831. [More Information]
Smith, M., Gill, P., Wetzig, N., Sourjina, T., Simes, R., Stockler, M. (2007). Bs06 patient-rated outcome measures were more sensitive than clinician-rated measures at distinguishing the effects of sentinel node biopsy and axillary clearance in the snac trial. ANZ Journal of Surgery, 77(Suppl. 1), A2-A2. [More Information]
Mark, D., Van de Werf, F., Simes, R., White, H., Wallentin, L., Califf, R., Armstrong, P. (2007). Cardiovascular disease on a global scale: defining the path forward for research and practice. European Heart Journal, 28(21), 2678-2684. [More Information]
Jonker, D., Oâ€™Callaghan, C., Karapetis, C., Zalcberg, J., Tu, D., Au, H., Berry, S., Krahn, M., Price, T., Simes, R., et al (2007). Cetuximab for the Treatment of Colorectal Cancer. New England Journal of Medicine, 357(20), 2040-2048. [More Information]
Grimison, P., Simes, R., Stockler, M. (2007). Development and validation of optimally weighted measures of global health-related quality of life (QoL) and utility based on a cancer-specific QoL instrument. Value in Health, 10(6), A226-A227.
Keech, A., Mitchell, P., Summanen, P., O'Day, J., Davis, T., Moffitt, M., Taskinen, M., Simes, R., Tse, D., Williamson, E., Merrifield, A., O'Connell, R., et al (2007). Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. The Lancet, 370(9600), 1687-1697. [More Information]
Stockler, M., O'Connell, R., Nowak, A., Goldstein, D., Turner, J., Wilcken, N., Wyld, D., Abdi, E., Glasgow, A., Beale, P., Dhillon, H., Heritier, S., Carter, C., Hickie, I., Simes, R., et al (2007). Effect of sertraline on symptoms and survival in patients with advanced cancer, but without major depression: a placebo-controlled double-blind randomised trial. The Lancet Oncology, 8(7), 603-612. [More Information]
Timmer, J., Ottervanger, J., de Boer, M., Boersma, E., Grines, C., Westerhout, C., Simes, R., Granger, C., Zijlstra, F., Primary Coronary Angioplasty vs Thrombolysisâ€“2 Trialists, C. (2007). Primary percutaneous coronary intervention compared with fibrinolysis for myocardial infarction in diabetes mellitus: results from the Primary Coronary Angioplasty vs Thrombolysis-2 trial. Archives of Internal Medicine, 167(13), 1353-1359. [More Information]
Duric, V., Butow, P., Sharpe, L., Boyle, F., Beith, J., Wilcken, N., Heritier, S., Coates, A., Simes, R., Stockler, M. (2007). Psychosocial factors and patients' preferences for adjuvant chemotherapy in early breast cancer. Psycho-Oncology, 16(1), 48-59. [More Information]
Gebski, V., Burmeister, B., Smithers, B., Foo, K., Zalcberg, J., Simes, R. (2007). Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. The Lancet Oncology, 8(3), 226-234. [More Information]
Edmond, J., French, J., Aylward, P., Wong, C., Stewart, R., Williams, B., de Pasquale, C., O'Connell, R., van den Berg, K., Van de Werf, F., Simes, R., et al (2007). Variations in the use of emergency PCI for the treatment of re-infarction following intravenous fibrinolytic therapy: impact on outcomes in HERO-2. European Heart Journal, 28(12), 1418-1424. [More Information]

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2006

Stockler, M., Sourjina, T., Harvey, V., Frances, P., Byrne, M., van Hazel, G., Fitzharris, B., Ackland, S., Finch, K., Lindsay, D., Gebski, V., Simes, R., Coates, A., et al (2006). A randomized trial of capecitabine given intermittently versus continuously versus classical CMF as first line chemotherapy for women with advanced breast cancer unsuited to more intensive treatment. Breast Cancer Research and Treatment, 100(Supplement 1), S278-S278.
Keech, A., Simes, R. (2006). Clinical trial design & management: The role of PPAR-ALPHA agonists in prevention of CVD. Atherosclerosis Supplements, 7(3), 174-174.
Keech, A., Simes, R., Barter, P., Best, J., Scott, R., Taskinen, M. (2006). Correction to the FIELD study report. The Lancet, 368(9545), 1415. [More Information]
Tonkin, A., Eckermann, S., White, H., Friedlander, D., Glasziou, P., Magnus, P., Kirby, A., Mulray, S., Denton, M., Sallaberger, M., Simes, R., et al (2006). Cost-effectiveness of cholesterol-lowering therapy with pravastatin in patients with previous acute coronary syndromes aged 65 to 74 years compared with younger patients: results from the LIPID study. American Heart Journal, 151(6), 1305-1312. [More Information]
Stockler, M., Tattersall, M., Boyer, M., Clarke, S., Beale, P., Simes, R. (2006). Disarming the guarded prognosis: predicting survival in newly referred patients with incurable cancer. British Journal of Cancer, 94(2), 208-212. [More Information]
Boersma, E., Westerhout, C., Simes, R., Weaver, W., Andersen, H., Armstrong, P., Granger, C., Grines, C., Zijlstra, F., Widimsky, P., et al (2006). Does time matter? A pooled analysis of randomized clinical trials comparing primary percutaneous coronary intervention and in-hospital fibrinolysis in acute myocardial infarction patients. European Heart Journal, 27(7), 779-788. [More Information]
Baigent, C., Keech, A., Kearney, P., Collins, R., Simes, R. (2006). Efficacy and safety of cholesterol-lowering treatment - Reply. The Lancet, 367(9509), 470-471.
Baigent, C., Keech, A., Kearney, P., Collins, R., Simes, R. (2006). Efficacy and safety of cholesterol-lowering treatment-authors' reply [letter]. The Lancet, 367(9509), 470-471. [More Information]
Edmond, J., French, J., Stewart, R., Aylward, P., de Pasquale, C., Williams, B., O'Connell, R., Simes, R., White, H. (2006). Frequency of recurrent ST-elevation myocardial infarction after fibrinolytic therapy in a different territory as a manifestation of multiple unstable coronary arterial plaques. American Journal of Cardiology, 97(7), 947-951. [More Information]
Sullivan, D., Forder, P., Simes, R., Whiting, M., Keech, A. (2006). Individual and combined effects of fenofibrate and sulphonylureas on HDL cholesterol and outcomes. XIV International Symposium on Atherosclerosis, Ireland: Elsevier Ireland Ltd.
Alexander, K., Newby, L., Bhapkar, M., White, H., Hochman, J., Pfisterer, M., Moliterno, D., Peterson, E., Van de Werf, F., Simes, R., Keech, A., et al (2006). International variation in invasive care of the elderly with acute coronary syndromes. European Heart Journal, 27(13), 1558-1564. [More Information]
Tonelli, M., Isles, C., Craven, T., Furberg, C., Tonkin, A., Pfeffer, M., Shepherd, J., Cobbe, S., Sacks, F., Simes, R., et al (2006). Letter regarding article by Tonelli et al, "Effect of pravastatin on rate of kidney function loss in people with or at risk for coronary disease" - Response. Circulation Journal, 113, e59-e60. [More Information]
Galbraith, S., Marschner, I., Simes, R. (2006). Missing data methods for the assessment of surrogate outcomes and treatment mechanisms in clinical trial substudies. Statistics in Medicine, 25(3), 415-431. [More Information]
Stocker, R., Pollicino, C., Gay, C., Nestel, P., Colquhoun, D., Whiting, M., Tonkin, A., Sullivan, D., Simes, R. (2006). Neither plasma coenzyme Q(10) concentration, nor its decline during pravastatin therapy, is linked to recurrent cardiovascular disease events: A prospective case-control study from the LIPID study. Atherosclerosis, 187(1), 198-204. [More Information]
Colquhoun, D., Soderberg, S., Kirby, A., Keech, A., Simes, R., Hague, W., Hamilton-Craig, I., Tonkin, A. (2006). Obesity and adipokines as risk factors for major coronary heart disease events in patients with CHD: Results from the lipid trial. XIV International Symposium on Atherosclerosis, Ireland: Elsevier Ireland Ltd.
Orlandini, A., Diaz, R., Wojdyla, D., Pieper, K., Van de Werf, F., Granger, C., Harrington, R., Boersma, E., Califf, R., Armstrong, P., Simes, R., et al (2006). Outcomes of patients in clinical trials with ST-segment elevation myocardial infarction among countries with different gross national incomes. European Heart Journal, 27(5), 527-533. [More Information]
Van Glabbeke, M., Verweij, J., Casali, P., Simes, R., Le Cesne, A., Reichardt, P., Issels, R., Judson, I., van Oosterom, A., Blay, J. (2006). Predicting toxicities for patients with advanced gastrointestinal stromal tumours treated with imatinib: a study of the European Organisation for Research and Treatment of Cancer, the Italian Sarcoma Group, and the Australasian Gastro-Intestinal Trials Gr. European Journal of Cancer, 42(14), 2277-2285. [More Information]
Askie, L., Ghersi, D., Simes, R. (2006). Prospective registration of clinical trials [Editorial]. Australian Journal of Physiotherapy, 52(4), 237-239. [More Information]
Gill, P., Gebski, V., Wetzig, N., Ung, O., Campbell, I., Collins, J., Sourjina, T., Coskinas, X., Stockler, M., Simes, R. (2006). Sentinel node (SN) based management causes less arm swelling and better quality of life than routine axillary clearance (AC): 1 year outcomes of the SNAC trial. Breast Cancer Research and Treatment, 100(Supplement 1), S14-S14.
Bushnell, C., Griffin, J., Newby, L., Goldstein, L., Mahaffey, K., Graffagnino, C., Harrington, R., White, H., Simes, R., Califf, R., et al (2006). Statin use and sex-specific stroke outcomes in patients with vascular disease. Stroke, 37(6), 1427-1431. [More Information]
Gebski, V., Lagleva, M., Keech, A., Simes, R., Langlands, A. (2006). Survival Effects of Postmastectomy Adjuvant Radiation Therapy Using Biologically Equivalent Doses: A Clinical Perspective - [Response]. Journal of the National Cancer Institute, 98(17), 1021-1022. [More Information]
Gebski, V., Lagleva, M., Keech, A., Simes, R., Langlands, A. (2006). Survival effects of postmastectomy adjuvant radiation therapy using biologically equivalent doses: a clinical perspective. Journal of the National Cancer Institute, 98(1), 26-38. [More Information]
Keech, A., Simes, R., Barter, P., Best, J., Scott, R., Taskinen, M. (2006). The FIELD study - Reply. The Lancet, 367(9517), 1142-1143. [More Information]
Lord, S., Irwig, L., Simes, R. (2006). When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials? Annals of Internal Medicine, 144(11), 850-855. [More Information]

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2005

Ackland, S., Jones, M., Tu, D., Simes, R., Yuen, J., Sargeant, A., Dhillon, H., Goldberg, R., Abdi, E., Moore, M., et al (2005). A meta-analysis of two randomised trials of early chemotherapy in asymptomatic metastatic colorectal cancer. British Journal of Cancer, 93(11), 1236-1243. [More Information]
O'Connell, R., Edmond, J., French, J., Aylward, P., Simes, R., White, H. (2005). A simple prognostic score for the re-infarction risk following fibrinolytic therapy for myocardial infarction - data from HERO-2. European Heart Journal, 26(Suppl 1), 561-561.
Ghersi, D., Wilcken, N., Simes, R. (2005). A systematic review of taxane-containing regimens for metastatic breast cancer. British Journal of Cancer, 93(3), 293-301. [More Information]
Gebski, V., Lagleva, M., Simes, R., Keech, A., Langlands, A. (2005). Adjuvant Radiotherapy in Early Breast Cancer: The Clinical Utility of Published Meta-Analysis. RANZCR, 55th Annual Scientific Meeting.
West, M., Blankenberg, S., Simes, R., Pollicino, C., Kirby, A., Nestel, P., White, H., Tonkin, A. (2005). Brain natriuretic peptide: a predictor of cardiovascular outcome in the Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) study. European Heart Journal, 26(Suppl 1), 718-718.
Duric, V., Stockler, M., Butow, P., Sharpe, L., Heritier, S., Beith, J., Boyle, F., Wilcken, N., Coates, A., Simes, R. (2005). Comparing patients' and their partners' preferences for adjuvant chemotherapy (ACT) in early breast cancer (EBC). Journal of Clinical Oncology, 23(16S), 546S-546S.
Gebski, V., Heritier, S., Pillai, A., Luke, V., Simes, R., Keech, A. (2005). Computer modelling of adaptive randomisation schemes in large scale randomised controlled trials. 20th International Workshop on Statistical Modelling, Sydney, Australia: University of Western Sydney.
Sinnaeve, P., Simes, R., Yusuf, S., Garg, J., Mehta, S., Eikelboom, J., Bittl, J., Serruys, P., Topol, E., Granger, C. (2005). Direct thrombin inhibitors in acute coronary syndromes: effect in patients undergoing early percutaneous coronary intervention. European Heart Journal, 26(22), 2396-403. [More Information]
Tonelli, M., Keech, A., Shepherd, J., Sacks, F., Tonkin, A., Packard, C., Pfeffer, M., Simes, R., Isles, C., Furberg, C., et al (2005). Effect of pravastatin in people with chronic kidney disease and diabetes mellitus. Hypertension, 46(4), 900-901.
Tonelli, M., Keech, A., Shepherd, J., Sacks, F., Tonkin, A., Packard, C., Pfeffer, M., Simes, R., Isles, C., Furberg, C., et al (2005). Effect of pravastatin in people with diabetes and chronic kidney disease. Journal of the American Society of Nephrology, 16(12), 3748-3754. [More Information]
Tonelli, M., Isles, C., Craven, T., Tonkin, A., Pfeffer, M., Shepherd, J., Sacks, F., Furberg, C., Cobbe, S., Simes, R., et al (2005). Effect of pravastatin on rate of kidney function loss in people with or at risk for coronary disease. Circulation, 112(2), 171-178. [More Information]
Keech, A., Simes, R., Barter, P., Best, J., Scott, R., Taskinen, M., Forder, P., Pillai, A., Davis, T., Glasziou, P., Sullivan, D., MacMahon, S., et al (2005). Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. The Lancet, 366(9500), 1849-1861. [More Information]
Baigent, C., Keech, A., Kearney, P., Blackwell, L., Buck, G., Pollicino, C., Kirby, A., Sourjina, T., Peto, R., Collins, R., Simes, R. (2005). Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. The Lancet, 366(9493), 1267-1278. [More Information]
Scott, R., Best, J., Forder, P., Taskinen, M., Simes, R., Barter, P., Keech, A. (2005). Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate (ISRCTN64783481). Cardiovascular Diabetology, 4(13), 1-9. [More Information]
Armstrong, P., Newby, L., Granger, C., Lee, K., Califf, R., Simes, R., Van de Werf, F., White, H. (2005). Letter regarding article by Armstrong et al, "Lessons learned from a clinical trial" - Response. Circulation, 111(23), e393-e393.
Labinaz, M., Mathias, J., Pieper, K., Granger, C., Lincoff, A., Moliterno, D., Van de Werf, F., Simes, R., White, H., Simoons, M., et al (2005). Outcomes of patients with acute coronary syndromes and prior percutaneous coronary intervention: a pooled analysis of three randomized clinical trials. European Heart Journal, 26(2), 128-136. [More Information]
Wong, C., French, J., Aylward, P., Stewart, R., Gao, W., Van de Werf, F., Armstrong, P., Simes, R., Raffel, O., Granger, C., et al (2005). Patients With Prolonged Ischemic Chest Pain and Presumed-New Left Bundle Branch Block Have Heterogeneous Outcomes Depending on the Presence of ST-Segment Changes. Journal of the American College of Cardiology, 46(1), 29-38. [More Information]
Duric, V., Stockler, M., Heritier, S., Boyle, F., Beith, J., Sullivan, A., Wilcken, N., Coates, A., Simes, R. (2005). Patients' preferences for adjuvant chemotherapy in early breast cancer: what makes AC and CMF worthwhile now? Annals of Oncology, 16(11), 1786-1794. [More Information]
Nestel, P., Baghurst, K., Colquhoun, D., Simes, R., Mehalski, K., White, H., Tonkin, A., Kirby, A., Pollicino, C. (2005). Relation of diet to cardiovascular disease risk factors in subjects with cardiovascular disease in Australia and New Zealand: analysis of the Long-Term Intervention with Pravastatin in Ischaemic Disease trial. American Journal of Clinical Nutrition, 81(6), 1322-1329. [More Information]
Carrick, S., Parker, S., Thornton, C., Ghersi, D., Simes, R., Wilcken, N. (2005). Single agent versus combination chemotherapy for metastatic breast cancer (Review). Cochrane Database of Systematic Reviews, 2005 (2), 1-22. [More Information]
Burmeister, B., Smithers, B., Gebski, V., Fitzgerald, L., Simes, R., Devitt, P., Ackland, S., Gotley, D., Joseph, D., Millar, J., Walpole, E., et al (2005). Surgery alone versus chemoradiotherapy followed by surgery for resectable cancer of the oesophagus: a randomised controlled phase III trial. The Lancet Oncology, 6(9), 659-668. [More Information]
Ghersi, D., Wilcken, N., Simes, R., Donoghue, E. (2005). Taxane containing regimens for metastatic breast cancer (Review). Cochrane Database of Systematic Reviews, 2005 (2), 1-119. [More Information]
Nestel, P., Blankenberg, S., Simes, R., Kirby, A., Tonkin, A. (2005). Tissue inhibitor of metalloproteinase (TIMP-1) is a predictor of recurrent cardiovascular events in the LIPID study. European Heart Journal, 26(Suppl 1), 257-257.
Stewart, R., White, H., Kirby, A., Heritier, S., Simes, R., Nestel, P., West, M., Colquhoun, D., Tonkin, A. (2005). White Blood Cell Count Predicts Reduction in Coronary Heart Disease Mortality With Pravastatin. Circulation, 111(14), 1756-1762. [More Information]

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2004

Cox, K., O'Connell, R., Stockler, M., Boyer, M., Beale, P., Simes, R. (2004). A randomized crossover trial of giving high-dose cisplatin with or without an overnight stay in hospital: Patients' preferences, quality of life, safety and resource use. Journal of Clinical Oncology, 22(14S), 547S-547S.
Lord, S., Ghersi, D., Gattellari, M., Wilcken, N., Thornton, C., Simes, J. (2004). Antitumour Antibiotic Containing Regimens For Metastatic Breast Cancer. Cochrane Database of Systematic Reviews, 4(CD003367), 1-123.
Boersma, E., Simes, R., Grines, C., Westerhout, C. (2004). Does time matter? Individual patient data-based meta-analysis of primary PCI versus fibrinolysis in acute myocardial infarction randomized trials. Circulation, 110(Suppl III), III 539-III 539.
Colquhoun, D., Keech, A., Hunt, D., Marschner, I., Simes, R., Glasziou, P., White, H., Barter, P., Tonkin, A. (2004). Effects Of Pravastatin On Coronary Events In 2073 Patients With Low Levels Of Both Low-Density Lipoprotein Cholesterol And High-Density Lipoprotein Cholesterol: Results From The Lipid Study. European Heart Journal, 25(9), 771-777. [More Information]
Kassem-Moussa, H., Mahaffey, K., Graffagnino, C., Tassisa, G., Sila, C., Simes, R., White, H., Califf, R., Bhapkar, M., Newby, L. (2004). Incidence and characteristics of stroke during 90-day follow-up in patients stabilized after an acute coronary syndrome. American Heart Journal, 148(3), 439-446. [More Information]
Armstrong, P., Newby, L., Granger, C., Lee, K., Simes, R., Van de Werf, F., White, H., Califf, R. (2004). Lessons learned from a clinical trial. Circulation, 110(23), 3610-3614. [More Information]
Carrick, S., Ghersi, D., Wilcken, N., Simes, R. (2004). Platinum Containing Regimens For Metastatic Breast Cancer. Cochrane Database of Systematic Reviews, 2(CD003374), 1-74.
Duric, V., Stockler, M., Butow, P., Sharpe, L., Beith, J., Sullivan, A., Boyle, F., Dhillon, H., Coates, A., Simes, R. (2004). Predictors of the benefits women consider necessary to make adjuvant chemotherapy (ACT) worthwhile for early breast cancer (EBC). Journal of Clinical Oncology, 22(14S), 73S-73S.
Kandzari, D., Granger, C., Simoons, M., White, H., Simes, R., Mahaffey, K., Gore, J., Weaver, W., Longstreth, W., Stebbins, A., et al (2004). Risk Factors For Intracranial Hemorrhage And Nonhemorrhagic Stroke After Fibrinolytic Therapy (From The Gusto-I Trial). American Journal of Cardiology, 93(4), 458-461. [More Information]
Keech, A., Best, J., Scott, R., Barter, P., Simes, R., Forder, P., Taskinen, M., FIELD study investigators, F. (2004). Significant lipid changes in a large-scale trial of fenofibrate to prevent cardiovascular disease in type 2 diabetes. Journal of the American College of Cardiology, 43(5), A462-A462.
Simes, R., Gebski, V., Keech, A. (2004). Subgroup analysis: application to individual patient decisions. Medical Journal of Australia, 180(9), 467-469. [More Information]
Barter, P., Best, J., Coleman, P., D'Emden, M., Davis, T., Drury, P., Ehnholm, C., Keech, A., Simes, R., et al (2004). The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Cardiovascular Diabetology, 3(December), 9 - 1-9 - 11. [More Information]

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2003

Glare, P., Virik, K., Jones, M., Hudson, M., Eychmuller, S., Simes, R., Christakis, N. (2003). A systematic review of physicians' survival predictions in terminally ill cancer patients. BMJ: British Medical Journal, 327(195), 195-198.
Magliano, D., Liew, D., Pater, H., Kirby, A., Hunt, D., Simes, R., Sundararajan, V., Tonkin, A. (2003). Accuracy of the Australian National Death Index: comparison with adjudicated fatal outcomes among Australian participants in the long-term intervention with Pravastatin in Ischaemic Disease (LIPID) Study. Australian and New Zealand Journal of Public Health, 27(6), 649-653. [More Information]
Pike, R., Keech, A., Simes, R. (2003). Clinical trials research in the new millennium: the International Clinical Trials Symposium, Sydney, 21-23 October 2002. Medical Journal of Australia, 178(7), 316-317.
Stewart, R., North, F., West, T., Sharples, K., Simes, R., Colquhoun, D., White, H., Tonkin, A. (2003). Depression and cardiovascular morbidity and mortality: cause or consequence? European Heart Journal, 24, 2027-2037. [More Information]
Hague, W., Forder, P., Simes, R., Hunt, D., Tonkin, A. (2003). Effect of pravastatin on cardiovascular events and mortality in 1516 women with coronary heart disease: Results from the Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) study. American Heart Journal, 145(4), 643-651. [More Information]
Kramer, J., Newby, L., Chang, W., Simes, R., Van de Werf, F., Granger, C., Lee, K., White, H., Piegas, L., Topol, E., et al (2003). International variation in the use of evidence-based medicines for acute coronary syndromes. European Heart Journal, 24(23), 2133-2141. [More Information]
Patel, A., Jones, M., Simes, R., Topol, E., Califf, R., Van, D., Betriu,, A., Ardissino,, D., Armstrong, P., Aylward, P., et al (2003). Primary coronary angioplasty compared with intravenous thrombolytic therapy for acute myocardial infarction: six-month follow up and analysis of individual patient data from randomized trials. American Heart Journal, 145(1), 48-57. [More Information]
Keech, A., Colquhoun, D., Best, J., Kirby, A., Simes, R., Hunt, D., Hague, W., Beller, E., Arulchelvam, M., Baker, J., et al (2003). Secondary prevention of cardio vascular events with long-term Pravastatin in patients with diabetes or impared fasting glucose: results from the LIPID trial. Diabetes Care, 26(10), 2713-2721. [More Information]
Ghersi, D., Wilcken, N., Simes, R., Donoghue, E. (2003). Taxane containing regimes for metastatic breast cancer. Cochrane Database of Systematic Reviews, 168(37), 3117-3120. [More Information]
Eckermann, S., Martin, A., Stockler, M., Simes, R. (2003). The benefits and costs of tamoxifen for breast cancer prevention. Australian and New Zealand Journal of Public Health, 27(1), 34-40. [More Information]

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2002

Coates, A., Thompson, J., McMullen, A., Simes, R., McCarthy, W., Hersey, P., Sillar, R., Mcleod, R., Gill, P., Coventry, B., Dhillon, H. (2002). Adjuvant Immunotherapy of Patients with High-Risk Melanoma Using Vaccinia Viral Lysates of Melanoma: Results of a Randomized Trial. Journal of Clinical Oncology, 20(20), 4181-4189.
Glasziou, P., Eckermann, S., Mulray, S., Simes, R., Martin, A., Kirby, A., Hall, J., White, H., Caleo, S., Tonkin, A. (2002). Cholesterol-lowering therapy with pravastatin in patients with average cholesterol levels and establisheed ischaemic heart disease: is it cost effective? Medical Journal of Australia, 177(8), 428-434. [More Information]
Zijlstra, F., Patel, A., Jones, W., Grines, C., Ellis, S., Garcia, E., Grinfeld, L., Gibbons, R., Ribeiro, E., Ribichini, F., Simes, R., et al (2002). Clinical characteristics and outcome of patients with early(<2h), intermediate (2-4h) and late (>4h) presentation treated by primary coronary angioplasty or thrombolytic therapy for acute myocardial infarction. European Heart Journal, 23(7), 550-557.
Simes, R., Furberg, C., Braunwald, E., Davis, B., Ford, I., Tonkin, A., Shepherd, J., Keech, A. (2002). Effects of pravastatin on mortality in patients with and without coronary heart disease across a broad range of cholesterol levels. European Heart Journal, 23(3), 207-215. [More Information]
Cuzick, J., Forbes, J., Edwards, R., Baum, M., Cawthorn, S., Coates, A., Hamed, H., Howell, A., Powels, T., Dhillon, H., Gebski, V., Simes, R. (2002). First results from the International Breast Cancer Intervention Study (IBIS-1): a randomised prevention trial. The Lancet, 360(9336), 817-824. [More Information]
Simes, R., Kirby, A., Keech, A., Hague, W., MacMahon, S., Hunt, D., Tonkin, A., Alyward, P., Colquhoun, D., Glasziou, P., et al (2002). Long-term effectiveness and safety of pravastatin in 9014 patients with coronary heart disease and average cholesterol concentrations: the LIPID trial follow up. The Lancet, 359, 1379-1387. [More Information]
Boersma, E., Harrington, R., Moliterno, D., White, H., Theroux, P., Van de Werf, F., Torbal, A., Armstrong, P., Wallentin, L., Wilcox, R., Simes, R., et al (2002). Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: a meta-analysis of all major randomised clinical trials. The Lancet, 359(9302), 189-198. [More Information]
Simes, R., Keech, A., et al (2002). Randomized, placebo-controlled trial of titrated intravenous lamifiban for acute coronary syndromes. Circulation, 105(3), 316-321.
Simes, R., Marschner, I., Hunt, D., Sullivan, D., Colquhoun, D., Hague, W., Stewart, R., Keech, A., Thompson, P., White, H., et al (2002). Relationship between lipid levels and clinical outcomes in the long-term intervention with pravastatin in ischemic disease (LIPID) trial: to what extent is the reduction in coronary events with pravastatin explained by on-study lipid levels? Circulation, 105(10), 1162-1169. [More Information]
West, M., White, H., Simes, R., Kirby, A., Watson, J., Anderson, N., Hankey, G., Simes, S., Hunt, D., Tonkin, A. (2002). Risk factors for non-haemorraghic stroke in patients with coronary heart disease and the effect of lipid-modifying therapy with pravastatin. Journal of Hypertension, 20(12), 2513-2517. [More Information]
Gebski, V., Simes, R. (2002). Survival plots for interpreting trial results. International Clinical Trials Symposium.
Al-Khatib, S., Huang, Y., Califf, R., Lee, K., Simoons, M., Van de Werf, F., White, H., Simes, R., Granger, C., Armstrong, P., et al (2002). Sustained ventricular arrythmias among patients with acute coronary syndromes with no ST-segment elevation: incidence, predictors and outcomes. Circulation, 106(3), 309-312. [More Information]
Armstrong, P., Newby, L., Califf, R., White, H., Harrington, R., Van de Werf, F., Granger, C., Simes, R., Hasselblad, V. (2002). The failure of orally administered glycoprotein IIb/IIIa inhibitors to prevent recurrent cardiac events. The American Journal of Medicine, 112(8), 647-658. [More Information]

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2001

Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, C., Liberati, A., et al (2001). Addition of drug/s to a chemotherapy regimen for metastatic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Basser, R., Henderson, I., Brunswick, C., Fossati, R., Liberati, A., et al (2001). Antitumor antibiotic containing regimins for metastatic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Hunt, D., Young, P., Simes, R., Hague, W., Mann, S., Owensby, D., Lane, G., Tonkin, A. (2001). Benefits of pravastatin on cardiovascular events and mortality in older patients with coronary heart disease are equal to or exceed those seen in younger patients. Annals of Internal Medicine, (134), 931-940.
Simes, R., Hague, W., Young, P., Hunt, D., Mann, S., Owensby, D., Lande,, G., Tonkin, A. (2001). Benefits of pravastatin on cardiovascular events and mortalty in older patients with coronary heart disease are equpal to or exceed those seen isn younder patients: results from LIPID Trial. Annals of Internal Medicine, 134 (10), 931-940.
Lumley, T., Simes, R., Gebski, V., Hudson, H. (2001). Combining components of quality of life to increase precision and evaluate trade-offs. Statistics in Medicine, 20(21), 3231-3249. [More Information]
Toner, G., Stockler, M., Boyer, M., Jones, M., Thomson, D., Harvey, V., Olver, I., Dhillon, H., McMullen, A., Gebski, V., Levi, J., Simes, R. (2001). Comparison of two standard chemotherapy regimens for good-prognosis germ-cell tumours: a randomised trial. The Lancet, 357(9528), 739-745. [More Information]
Jeffery, H., Simes, R., Lawrence, G., Tudehope, D., Baumann,, K., Gill, A., Cole, M., Drew, J., McPhee,, A., Ratcliffe, J., et al (2001). Enteral human IgG for prevention of necrotising enterocolitis: a placebo-controlled, randomised trial. The Lancet, 357, 2090-2094.
Gebski, V., Veness, M., Simes, R., Shakespeare, T. (2001). Improving interpretation of clinical studies by use of confidence intervals, clinical significnce cureves, and risk analysis. The Lancet, 357, 1349-1353.
Shakespeare, T., Gebski, V., Veness, M., Simes, R. (2001). Improving interpretation of clinical studies by use of confidence levels, clinical significance curves, and risk-benefit contours. The Lancet, 357(9265), 1349-1353.
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, R., Liberati, A., et al (2001). Larger vs smaller dose of the same drug/s regimen for metastatic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Marschner, I., Simes, R., Colquhoun, D., Glasziou, P., Harris, P., Singh, B., Friedlander, D., White, H., Thompson, P., Tonkin, A. (2001). Long-term risk stratification for survivors of acute coronary syndromes. Journal of the American College of Cardiology, 38(1), 56-63. [More Information]
Simes, R., Coates, A. (2001). Patient preferences for adjuvant chemotherapy of early breast cancer: How much benefit is needed? Journal of the National Cancer Institute, 30, 146-152. [More Information]
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, R., Liberati, A., et al (2001). Platinum containing reimens for metastatic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, R., Liberati, A., et al (2001). Single agent vs combination chemotherapy for metastatic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, C., Liberati, A., et al (2001). Taxane containing regimens for metastatsic breast cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.
Ghersi, D., Simes, R., Stockler, M., Tattersall, M., Wilcken, N., Henderson, I., Basser, R., Brunswick, C., Fossati, R., Liberati, A., et al (2001). Two drug combinations vs combinations of 3 or more cytotoxic drugs for meastatic brest cancer [protocol]. Cochrane Database of Systematic Reviews, Issue 4, 1-4.

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2000

Stockler, M., Wilcken, N., Ghersi, D., Simes, R. (2000). Systematic reviews of chemotherapy and endocrine therapy in metastatic breast cancer. Cancer Treatment Reviews, 26(3), 151-168. [More Information]

Selected Grants

2023

Rewarding Research 2024, Simes R, Faculty of Medicine and Health/FMH Rewarding Research Success

2022

Supporting Australian Brain Cancer Research with an integrated network of platforms, Jeffree R, Day B, Gedye C, Koh E, Leonard R, Sim H, Varikatt W, Hansen D, Cossio D, Harrup R, Gan H, Zalcberg J, Simes R, O'Brien T, Drummond K, Pinkham M, Ormsby R, Gomez G, Alexander K, Buckland M, Good N, Sachchithananthan M, Scott A, Whittle J, Gately L, Ziegler D, Vajdic C, Lipworth W, Dickinson J, Quinn L, Aitken J, Lwin Z, Hansford J, Yuile A, Agar M, Kichenadasse G, Truran D, Francois G, Chin W, Kong B, Gabriel J, Lee A, Turner C, Evans S, Ng W, Sullivan R, Pitson S, Nguyen A, Department of Health and Aged Care (Federal - administered by NHMRC)/2022 MRFF Australian Brain Cancer Research Infrastructure
Clinical development of a self-amplifying pan-tumour theranostic, Hogg P, Simes R, Codd R, Scott A, Barrington S, Stockler M, Ho Shon I, Gebski V, Goldstein D, Thompson S, Cancer Institute NSW/Translational Program Grant
LUMOS: Low and Anaplastic Grade Glioma Umbrella Study of Molecular Guided TherapieS, Gan H, Simes R, Sim H, Yip S, Thavaneswaran S, Department of Health and Aged Care (Federal)/MRFF - Rare Cancers, Rare Diseases and Unmet Need (RCRDUN)

2021

Innovations in Clinical Trials Research: from personalised medicine to population health, Simes R, National Health and Medical Research Council (NHMRC)/Investigator Grant
New Frontiers in Personalised Prevention of Coronary Artery Disease, Figtree G, Celemajer D, Chow C, Fazekas de St Groth B, Drummond G, Ellinor P, Grieve S, Jenkins A, Kassiou M, Keech A, Kovacic J, Larance M, Marwick T, McGuire H, Meikle P, Nicholls S, O'Sullivan J, Peter K, Ritchie R, Shaw J, Simes R, Walley T, Wilson A, Department of Health and Aged Care (Federal)/MRFF - Frontier Health and Medical Research Program, Stage One
SAFER (AUS) Trial: Screening for Atrial Fibrillation with ECG to Reduce stroke - a randomised controlled trial, Freedman B, Nelson M, Keech A, Lowres N, Hespe C, Cadilhac D, Mant J, Thijs V, Simes R, Department of Health and Aged Care (Federal - administered by NHMRC)/MRFF International Clinical Trial Collaborations

2020

Apixaban Twice Daily vs Rivaroxaban Once Daily for the Treatment of Venous Thromboembolism: A randomised controlled trial COBRRA, Chen V, Castellucci L, Brighton T, Tran H, Rodger M, Le Gal G, Kahn S, Simes R, Reddel C, Morton R, Department of Health and Aged Care (Federal)/MRFF - International Clinical Trials Collaborations Program

2019

COLchicine CARDIovascular Outcomes in Acute Coronary Syndrome COLCARDIO-ACS Study, Keech A, Patel S, Hillis G, Nicholls S, Thompson P, Newby D, Simes R, Morton R, Gebski V, Psaltis P, National Health and Medical Research Council (NHMRC)/Clinical Trials and Cohort Studies
Embedding Research (and Evidence) in Cancer Healthcare - EnRICH, Simes R, NSW Health/Health Statewide Biobank
SEQUential ImmunoTherapy in patients with Underserved Rare cancers SEQUITUR, Khasraw M, Simes R, Cure Brain Cancer Foundation/Innovation Grant

2018

Better Outcomes through Innovations in Clinical Trials: from Personalised Medicine to Population Health, Simes R, Keech A, Gebski V, Stockler M, Jenkins A, National Health and Medical Research Council (NHMRC)/Program Grants
Centre for Translational Breast Cancer Research TransBCR : delivering laboratory discoveries to the clinic, Simes R, National Health and Medical Research Council (NHMRC)/Centres of Clinical Research Excellence

2017

Improving oesophageal adenocarcinoma outcomes through understanding genomics and treatment toxicity, Simes R, Waddell N, Barbour A, Fitzgerald R, Liu X, Nones K, Pearson J, Watson D, National Health and Medical Research Council (NHMRC)/Project Grants
Personalisation of Aspirin Adjuvant Therapy in Patients with Colorectal Cancer, Sieber O, Simes R, Segelov E, Segelov E, Sieber O, National Health and Medical Research Council (NHMRC)/Project Grants
Molecular Screening and Therapeutics (MoST) Study, Simes R, Sydney Cancer Institute/Research Grant
Personalisation of Aspirin Adjuvant Therapy in Patients with Colorectal Cancer, Simes R, Sieber O, National Health and Medical Research Council (NHMRC)/Project Grants
Cochrane Breast Cancer Group, Wilcken N, Goodwin A, O'Connell D, Tan-Koay A, Berber S, Willson M, Bulsara M, Norris S, Stuart K, Hickey B, Saunders C, Simes R, National Health and Medical Research Council (NHMRC)/Cochrane Collaboration Funding
Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma: the CODEL trial, Hovey E, Nowak A, Simes R, McDonald K, Drummond K, Buckland M, Koh E, Cher L, Cancer Australia/Priority Driven Collaborative Cancer Research Scheme
ASCOLT: Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers. An International, Multi-centre, Double Blind, Randomised Trial., Jeffery M, Segelov E, Simes R, Tebbutt N, Zalcberg J, Chia J, Chantrill L, Cancer Australia/Priority Driven Collaborative Cancer Research Scheme

2016

Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versusRadiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma: the CODEL trial, Hovey E, Nowak A, Simes R, McDonald K, Drummond K, Buckland M, Koh E, Cher L, Cancer Council NSW/Research Project Grants
Translating Clinical Trials Research, Simes R, National Health and Medical Research Council (NHMRC)/Career Awards: Research Fellowships
2016 NSW Premier's Awards for Outstanding Cancer Research - Outstanding Cancer Researcher of the Year Award, Simes R, Cancer Institute NSW/NSW Premiers Awards for Outstanding Cancer Research
EnRICH - Embedding Research in Cancer Healthcare, Simes R, University of Sydney - Sydney Catalyst Translational Cancer Research/Research Grant
MoST - The Cancer Molecular Screening and Therapeutics Program, Simes R, Health Administration Corporation/Research Grant
EnRICH - Embedding Research and Evidence in Cancer Healthcare, Simes R, Sydney Local Health District/Research Support
Sydney Catalyst - the Translational Cancer Research Centre of central Sydney and regional NSW, Boyer M, Simes R, Hogg P, Butow P, Thomas D, Young J, Vadas M, Cancer Institute NSW/Translational Cancer Research Centre
INTEGRATE II Bayer HealthCare Pharmaceuticals inc, Simes R, Bayer HealthCare Pharmaceuticals Inc/Clinical Trial
RES: Grant Agreement with the Australian Communities Foundation for the "Brain Cancer Biobanking Australia" project under the Isabella and Marcus Paediatric Brainstem Tumour Fund Professor John Simes & Mythily Mariasegaram, Simes R, Australian Communities Foundation Limited/Grant
Start-Up activities with or without a pilot and definitive randomised double-blind placebo-controlled trial or oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting, Grimison P, Haber P, Stockler M, Lintzeris N, Simes R, McGregor I, Olver I, Allsop D, Gedye C, Kirby A, NSW Health./Research Project Support
Phase II randomised placebo-controlled, double blind, multisite study of acetazolamide versus placebo for management of cerebral oedema in recurrent and/or progressive HGG requiring treatment with dexamethasone - The ACED trial, Agar M, Vardy J, Koh E, Simes R, Nowak A, Wheeler H, Barnes E, Hovey E, Cancer Australia/Priority Driven Collaborative Cancer Research Scheme
Brain Cancer Biobanking Australia, Simes R, Cancer Council NSW/Research Grant

2015

RES: USYD and Astrazeneca _ PHAEDRA/PHAEDRE, Simes R, AstraZeneca Australia Pty Ltd/Research Support
VERTU - VEliparib, Radiotherapy and Temozolomide trial in Unmethylated MGMT Glioblastoma, Khasraw M, Simes R, Rosenthal M, McDonald K, Koh E, Ashley D, Buckland M, Barnes E, Goh C, Yip S, Cancer Council NSW/Priority-driven Collaborative Cancer Research Scheme
Acetazolamide plus dexamethasone versus dexamethasone alone for management of cerebral oedema in high grade gliomas, Simes R, Cure Brain Cancer Foundation/Research Grant
SCOT - Short Course Oncology Therapy - A study of adjuvant chemotherapy in colorectal cancer, Haydon A, Segelov E, Zalcberg J, Simes R, Walpole E, Yip D, Price T, Jefford M, Cancer Australia/Priority Driven Collaborative Cancer Research Scheme
Phase III trial of Concurrent & Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma, Nowak A, Rosenthal M, Simes R, Ryan G, Drummond K, Cancer Australia/Priority Driven Collaborative Cancer Research Scheme

2014

VERTU - VEliparib, Radiotherapy and Temozolimde trial in newly diagnosed Unmethylated MGMT Glioblastoma, Khasraw M, Simes R, Cure Brain Cancer Foundation/Research Grant
CONTROL NETS: Capecitabine ON Temozolomide Radionuclide therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study, Simes R, Unicorn Foundation/Clinical Trial
Grey Matters - National Brain Cancer Biobanking Consortium Project - Cooperative Trials Group for Neuro-Oncology (COGNO), Simes R, Cancer Council NSW/Seed Funding
National Brain Cancer Biobanking Consortium, Simes R, Roche Products Pty Ltd/Research Grant
ASCOLT: Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers. An International, Multi-centre, Double Blind, Randomised Trial, Segelov E, Simes R, Tebbutt N, Zalcberg J, Sommeijer D, Chia J, Cancer Australia/Priority Driven Collaborative Cancer Research Scheme

2013

Technical services of a genomic cancer clinical trial initiative (GCCTI) to develop mutation-specific cancer clinical trials protocols, Stockler M, Simes R, Vachan B, Sjoquist K, Lee C, Yip S, Cancer Australia/Request for Tender
PETACC-6: Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer, Price T, Harvey J, Simes R, Zalcberg J, Karapetis C, Tebbutt N, Cancer Australia/Priority Driven Collaborative Cancer Research Scheme
PETACC-6: Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer, Price T, Harvey J, Tebbutt N, Simes R, Zalcberg J, Karapetis C, Cancer Council NSW/Research Project Grants

2012

COGNO infrastructure funding for support, development and conduct of clinical trials and translational research, Hovey E, Simes R, Koh E, Agar M, McDonald K, Wheeler H, Cancer Institute NSW/Cooperative Clinical Trial (CCT) Grants
Improving patient outcomes for patients with Gastrointestinal (GI) cancer through clinical trials research: An application on behalf of the Australasian Gastro-Intestinal Trials Group (AGITG), Goldstein D, Simes R, Abdi E, Ackland S, Pavlakis N, Shannon J, Cancer Institute NSW/Cooperative Clinical Trial (CCT) Grants
The biological basis of success or failure to the anti-VEGF agent, bevacizumab in patients with recurrent glioblastoma, Simes R, McDonald K, Brown C, Yip S, Cancer Council NSW/Research Project Grants
Advancing the evidence base for care and policy in priority health areas, Simes R, Keech A, Gebski V, Stockler M, Caterson I, Colagiuri S, Schofield D, Marschner I, National Health and Medical Research Council (NHMRC)/Program Grants
Centre of Research Excellence for Translational Breast Cancer Research: From Discovery to Better Health Outcomes, Lindeman G, Mann B, Desai J, Forbes J, Fox S, Liew D, McArthur G, Simes R, Sutherland R, Visvader J, National Health and Medical Research Council (NHMRC)/Centres of Research Excellence
Evaluation of a web-based tool for estimating and explaining prognosis in advanced cancer, Kiely B, Stockler M, Butow P, Tattersall M, Simes R, Cancer Australia/Priority Driven Collaborative Cancer Research Scheme

2011

Pathogenesis and risk assessment of coronary artery disease, Simes R, Kirby A, Meikle P, National Health and Medical Research Council (NHMRC)/Project Grants
Biomarker for Cardiovascular Risk Assessment in Europe (BiomarCaRE), Blankenberg S, Kuulasmaa K, Salomaa V, Breek H, Pasterkamp G, Hofer I, Illig T, Peters A, Koenig W, Weinberger K, Ziegler A, Siebert U, Schnell-Inderst P, Wollert K, Dent A, Bogaard P, Werner E, Wild P, Munzel T, Njolstad I, Mathiesen E, Zeller T, Schnabel R, Biasucci L, Iacoviello L, Crea F, Volzke H, Felix S, Bobak M, Kee F, Dallongeville J, Sans S, Wiklund P, Metspalu A, Jorgensen T, Ferrario M, Tunstall-Pedoe H, Muller C, Rothenbacher D, Konig W, Ridker P, Simes R, Tonkin A, Anand S, European Commission (Belgium)/Seventh Framework Network of Excellence Programme
Maintain the National Clinical Trials Register, 01/04/2012 - 31/12/2016, Simes R, Askie L, National Health and Medical Research Council (NHMRC)/Enabling Grants
Senior Principal Research Fellowship, Simes R, National Health and Medical Research Council (NHMRC)/Career Awards: Australian Fellowship
TACTIC CTC AGITG/AMGEN, Simes R, Australasian Gastro-Intestinal Trials Group/Research Support
GeneAtlas Personal Microarray System, Richardson D, Scolyer R, Stocker R, Weninger W, Black J, Allen D, Murray M, Mason R, Twigg S, King N, Horvath L, Lovicu F, Lee C, Halliday G, Lovejoy D, Joshua D, Sharland A, Roufogalis B, Hambly B, Morris B, Bao B, Bishop A, Hibbs D, Lane D, Zhou F, Hanrahan J, Dixon K, Rendina L, Byrne M, Naylor M, Cole N, Jansson P, Dong Q, Codd R, Payne R, Assinder S, Chadban S, Fraser S, McLennan S, Suryo Rahmanto A, Lai D, Yu Y, Ju Y, Buckland M, Kovacevic Z, Saletta F, Zreiqat H, Kalinowski D, Groundwater P, Simes R, Zhang D, Boyer M, Murphy C, National Health and Medical Research Council (NHMRC)/Equipment Grant
Translating Health Discovery Superscience, Askie L, Simes R, Department of Education and Training (Federal)/National Collaborative Research Infrastructure Strategy (NCRIS)
Sydney Catalyst: the Translational Cancer Research Centre of Central Sydney and Regional NSW., Simes R, Cancer Institute NSW/Translational Health Services Research Grant

2010

NHMRC Clinical Trials Centre, University of Sydney and the Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre CCTDU, Simes R, Cancer Australia/Support for Cancer Clinical Trials - Existing National Cooperative Oncology groups

2009

Temporary account for NHMRC CTC funds, Simes R, Commonwealth Department of Health and Ageing/Research Grant
Biostatistics, quality assurance and data systems for cancer trial groups activities based at the NHMRC Clinical Trials Centre, Gebski V, Simes R, Hague W, Gainford M, Stockler M, Goldstein D, Friedlander M, Grimison P, Cancer Institute NSW/Clinical Trials Infrastructure Grants
Development and operational support for AGITG and ANZGOG through the NHMRC Clinical Trials Centre: A NSW-led initiative, Simes R, Friedlander M, Goldstein D, Gainford M, Cancer Institute NSW/Clinical Trials Infrastructure Grants
Development and operational support for ALTG, ANZUP and GOGNO through the NHMRC Clinical Trials Centre: A NSW-led initiative, Stockler M, Simes R, Grimison P, Hague W, Cancer Institute NSW/Clinical Trials Infrastructure Grants

2008

Temporary account for NHMRC CTC funds, Simes R, Department of Health and Aged Care (Federal)/Research Support
An international randomised trial of low-dose aspirin to prevent recurrent venous thromboembolism (INSPIRE), Brighton T, Eikelboom J, Ockelford P, Simes R, Gallus A, Agnelli G, Kakkar A, Ockleford P, Xavier D, Hague W, Mister R, National Health and Medical Research Council (NHMRC)/Project Grants
Temporary account for NHMRC CTC funds , Simes R, Department of Health and Aged Care (Federal)/Research Support
Cancer Clinical Trials Development Unit, Simes R, Fisher R, Salkeld G, Ackland S, Cancer Australia/Support for Cancer Clinical Trials

2007

Clinical trials advances for better health outcomes, Simes R, Keech A, Gebski V, Stockler M, National Health and Medical Research Council (NHMRC)/Project Grants
Australasian Gastro-Intestinal trials Group, Simes R, Cancer Australia/Support for Cancer Clinical Trials - Existing National Cooperative Oncology groups
Cooperative Trials Group for Neuro-Oncology (COGNO), Rosenthal M, Simes R, Cancer Australia/Support for Cancer Clinical Trials
Preop chemoradiotherapy&postop chemo with capeciabine&oxaliplatin vs capecitabine alone in locally a, Price T, Harvey J, Tebbutt N, Hruby G, Bydder S, Simes R, Zalcberg J, Cancer Australia/Priority Driven Collaborative Cancer Research Scheme

2006

NHMRC - Research Fellowship, Simes R, National Health and Medical Research Council (NHMRC)/Established Career Fellowships

2005

ASPIRE Study to prevent recurrent venous thromboembolism (VTE), Ehle D, Simes R, Health Research Council of New Zealand (NZ)/BLO Project
Nhmrc Clinical Trials Centre Clinical Trials Methodology And Practice Consultancy, Incorporating Utilisation And Enhancement Of A Web-Based Electronic Clinical Trials Data Management System And Repository, Keech A, Simes R, Gebski V, Hague W, Stockler M, National Health and Medical Research Council (NHMRC)/Enabling Grants
Australian Clinical Trials Registry, Simes R, National Health and Medical Research Council (NHMRC)/Enabling Grants
FIELD substudies, research and analysis., Keech A, Simes R, Laboratoires Fournier/Research grant
Establishment, maintenance and operation of The Australian Clinical Trials Registry, Askie L, Simes R, Wood L, Bayer Global/Project Support

2004

Intermediate and high risk localized, completely resected, gastrointestinal stromal tumors (GIST) expressing c-KIT receptor: a controlled randomised trial on adjuvant Imatinib mesylate (Glivec), versus no further therapy after complete surgery, Yip S, Zalcberg J, Conley R, Lynch K, Simes R, Therasse P, Australasian Gastro-Intestinal Trials Group/Research Grants
Sentinal node biopsy versus axillary clearence in breast cancer: the SNAC trial, Gebski V, Simes R, Stockler M, National Breast Cancer Foundation/Kathleen Cuningham Research Grant
Clinical trials operations and statistical services grant, Simes R, Cancer Institute NSW/Research Grant
Infrastructure support for the AGITG and ANZGOG through the NHMRC Clinical Trials Centre - A NSW led initiative, Simes R, Stockler M, Cancer Institute NSW/Research Grant
Intermediate and high risk resected gastro-intestinal stromal tumours expressing kit: RCT of adjuvant mesylate, Kotasek D, Mann B, Simes R, Smithers B, Van Hazel G, Waring P, Zalcberg J, Cancer Council NSW/Research Project Grants
Not known, Simes R, Astra/Gastroenterological Society of Australia/Research Grant
Agreement for the provision of funding to enable the development of an interim clinical trials registry, Ghersi D, Goldstein D, Nutt M, Simes R, National Health and Medical Research Council (NHMRC)/Research Support
NHF Lipid Trial, Simes R, National Heart Foundation of Australia/Default scheme FPRx139 SCHx349
LIPID and LIPID Cohort Studies (BMS), Hague W, Keech A, Simes R, Bristol Myers Squibb/Research Grant

2003

Not Known - To be advised, Simes R, AGITG/AGITG Trials
ASPIRE Study to prevent recurrent venous thromboembolism (VTE) - Bayer, Simes R, Bayer Global/Research Grants
A phase III randomised study of Cetuximab(Erbitux C225) and best supportive care vs. supportive care in patients with pre-treated metastatic epidermal growth factor receptor (EGEFR)- postive colorectal carcinoma., Conley R, Sigal E, Simes R, Bristol Myers Squibb/Research Grants
Low-dose aspirin to prevent venous thromboembolism (ASPIRE) study: a multicentre randomised trial, Baker R, Brighton T, Eikelboom J, Rodgers A, Simes R, Brighton T, Baker R, National Health and Medical Research Council (NHMRC)/Project Grants
A randomised phase II study evaluating a weekly schedule of Docetaxel (Taxotere R) with cisplatin and 5-FU (wTCF) or with Capecitabine (Xeloda R) (wTX) in advanced oesophago-gastric cancer., Conley R, Simes R, Stockler M, Australasian Gastro-Intestinal Trials Group./BLO Project
ASPIRE Study to prevent recurrent venous thromboembolism (VTE) - NSW Health, Simes R, NSW Health/Research Grant

2002

Advances in clinical trials research and evidence-based decision making, Gebski V, Keech A, Marschner I, Simes R, Stockler M, National Health and Medical Research Council (NHMRC)/Program Grants
Australian-based cochrane collaboration activities - COLLABORATIVE Review Group with editorial base in Australia, Ghersi D, Simes R, DHA/Cochrane Collaborative Groups Funding Scheme
ANZGOG #02-01 A phase II trial of weekly docetaxel (taxetere) for patients with relapsed ovarian cancer who have previously received paclitaxel, Burrell K, Hannah C, Simes R, Australasian Gastro-Intestinal Trials Group./BLO Project

2001

Patient preferences for adjuvant chemotherapy for early breast cancer: what makes it worthwhile?, Coates A, Francis P, Reaby L, Simes R, Stockler M, National Health and Medical Research Council (NHMRC)/Project Grants
NHMRC Clinical Trials Centre, Keech A, Simes R, National Health and Medical Research Council (NHMRC)/Centres of Clinical Research Excellence
Cochrane Breast Cancer Group, Simes R, DHA/Cochrane Collaborative Groups Funding Scheme
Clinical medicine and science, Simes R, National Health and Medical Research Council (NHMRC)/Established Career Fellowships

2000

Antidepressants and subjective well-being in advanced cancer: a double-blind randomised trial of Sertraline and St Johns Wort, Simes R, Stockler M, Wilcken N, Cancer Council NSW/Research Project Grants
NHMRC-CTC support of GOG and ANZGOTG Gynaecologic Oncology Clinical Trials research agreement between the University of Sydney and the American College of Obstetricians and Gynecologists, Friedlander M, Sharp M, Simes R, Yip S, American College of Obstetricians and Gynecologists/BLO Project

1999

National Breast Cancer Centre: Cochrane review group, Simes R, Ghersi D, Cancer Council NSW/National Breast Cancer Centre Grant
Lipid BMS, Simes R, National Heart Foundation of Australia/Medical Research Funds
Lipid C-E study, Hall J, Simes R, Glasziou P, National Heart Foundation of Australia/Medical Research Funds
Symphony, Keech A, Simes R, The Cleveland Clinic Foundation/Contract Research
Provision of assessment and research related services on medical technologies and procedures for the Medical Services Advisory Committee (MSAC), Eckermann S, Eckermann S, Gebski V, Ghersi D, Howard K, Irwig L, Keech A, Lord S, Salkeld G, Simes R, Stockler M, Department of Health and Aged Care (Federal)/Research Support
The HERO-2 study., Keech A, Simes R, The Medicines Company (USA)/Project Grant
Coordinated program of clinical trials research, Ackland S, Simes R, Bell D, Cancer Council NSW/Infrastructure Development Grant
Systematic reviews of randomised controlled trials of chemotherapy and endocrine therapy in advanced breast cancer, Brunswick C, Henderson I, Simes R, Ghersi D, US Army Medical Research Acquisition Activity/Breast Cancer Research Program Grant
AGITG, Simes R, Australasian Gastro-intestinal Trials Group../Medical Research Funds
Clinical trials unit (1997), Simes R, National Health and Medical Research Council (NHMRC)/Program, Unit, Centre, and Institute Grants
Fournier Clinical Trial - Finland, Simes R, Laboratories Fournier (France)/Research Support
Lipid study, Simes R, National Heart Foundation of Australia/Medical Research Funds
Breast Cancer Clinical Trials Group, Simes R, ANZ Breast Cancer Trials Group Ltd/Project Grants
An open prospective randomised comparison of hirulog versus heparin in patients receiving aspirin and thrombolysis (Streptokinase) for the treatment of AMI, Simes R, The Medicines Company (USA)/Research Support

1998

Research entitled Paragon B between the University of Sydney and Duke University and Hoffman-La Roche, Inc., Simes R, Spear L, Duke University (USA)/BLO Project

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Professor John Simes

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