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Unit of study_
CLTR5005: Biomarker Studies
2024 unit information
Identifying the right patients for the right drug at the right time is a major goal for improving patient care. Using biomarkers to help us personalise medicine is one strategy. The discovery of new biomarkers and the development of new biomarker-directed therapies raise high hopes for personalised medicine. Despite their promise, claims of clinical benefit of biomarker use still requires careful evaluation. This unit will teach candidates how to embed biomarker studies and translational research into clinical trial designs. The special skills and techniques of translational research will be highlighted in this unit. Candidates will understand the potential uses for biomarkers in clinical practice; how to use study designs relevant for biomarker evaluation and how to incorporate biomarker studies and biospecimen (eg tissue and blood) collection into clinical research projects. Candidates will learn the difference between prognostic, predictive and surrogate biomarkers and biostatistical considerations in their analysis. The complexities of international guidelines and regulations regarding patient consent, biospecimen collection and shipment will be highlighted.
Unit details and rules
Managing faculty or University school:
Medicine and Health
| Study level | Postgraduate |
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| Academic unit | NHMRC Clinical Trials Centre |
| Credit points | 6 |
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Prerequisites:
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CLTR5001 and CLTR5007 |
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Corequisites:
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None |
| Prohibitions:
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None |
| Assumed knowledge:
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None |
At the completion of this unit, you should be able to:
- LO1. Module 1: Basic concepts (a) Describe the potential clinical use of biomarkers as medical tests for screening and diagnosis of disease, prognosis, prediction of treatment response, and monitoring treatment.
- LO2. Module 1: Basic concepts (b) Identify the stages of biomarker discovery and evaluation.
- LO3. Module 1: Basic concepts (c) Describe the common types of study designs used to demonstrate ‘proof-of-concept’ for a biomarker as a medical test, evaluate test reliability, and test accuracy.
- LO4. Module 1: Basic concepts (d) Calculate and interpret basic measures of test accuracy (sensitivity and specificity, positive and negative predictive values, receiver operator characteristic curve).
- LO5. Module 2: Biomarker discovery (a) Describe general approaches for biomarker discovery
- LO6. Module 2: Biomarker discovery (b) Identify common types of biospecimens used for biomarker research
- LO7. Module 2: Biomarker discovery (c) Describe common laboratory techniques and latest technologies
- LO8. Module 2: Biomarker discovery (d) Describe requirements of laboratory methods and quality control procedures.
- LO9. Module 2: Biomarker discovery (e) Describe the other major practical challenges for exploratory biomarker research.
- LO10. Model 3: Translating discovery to clinical application – Study design (a) Describe the key design elements for treatment trials incorporating biomarkers, including trials of biomarker targeted therapies.
- LO11. Model 3: Translating discovery to clinical application – Study design (b) Describe the advantages and disadvantages of classical, targeted and non-targeted biomarker-stratified trial designs.
- LO12. Model 3: Translating discovery to clinical application – Study design (c) Identify the limitations of single arm studies for evaluation of a biomarker.
- LO13. Model 3: Translating discovery to clinical application – Study design (d) Describe alternative designs to improve trial efficiency.
- LO14. Module 4: Statistical considerations in biomarker studies (a) Interpret data from biomarker-stratified trials.
- LO15. Module 4: Statistical considerations in biomarker studies (b) Interpret multivariable regression models to adjust for conventional clinical markers to determine the clinical value of a biomarker.
- LO16. Module 4: Statistical considerations in biomarker studies (c) Distinguish between the prognostic and surrogate properties of a biomarker to determine when a biomarker can be used as a valid surrogate marker.
- LO17. Module 5: Practical Implementation – Biospecimens and laboratory analyses (a) Describe ethical considerations, consent and regulatory requirements.
- LO18. Module 5: Practical Implementation – Biospecimens and laboratory analyses (b) Describe common methods for biospecimen collection, processing, storage and retrieval
- LO19. Module 5: Practical Implementation – Biospecimens and laboratory analyses (c) Identify key factors determining feasibility
- LO20. Module 5: Practical Implementation – Biospecimens and laboratory analyses (d) Develop a study protocol outline for biomarker study involving biospecimens, including a handbook for biospecimen collection and processing
- LO21. Module 5: Practical Implementation – Biospecimens and laboratory analyses (e) Understand the significance of biobanking in clinical trials
Unit availability
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Modes of attendance (MoA)
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