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Unit of study_
CLTR5004: Advanced Trial Design
2024 unit information
Candidates will be taught skills to design and interpret equivalence and non-inferiority trials, cluster randomised trials and crossover trials. Biomarker-based designs are also covered including enrichment, hybrid and novel designs such as basket, umbrella, and platform trials. The pros and cons of each design are outlined. The unit will equip students with the ability to determine the most appropriate and optimal design to answer a clinical research question. Special aspects relating to cross-over studies will be taught. The difference between prognostic and predictive factors will be illustrated. Techniques to validly incorporate composite end points and co-primary endpoints will be learnt. Skills to incorporate sub-studies into clinical research projects will be covered in this unit.
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. Determine the appropriate study design that will provide the best evidence to answer a clinical research question.
- LO2. Understand the impact of non-compliance on design, analysis and interpretation of results.
- LO3. Understand the difference between prognostic and predictive factors.
- LO4. Have knowledge of biomarker-based designs including basket, platform, and umbrella. Additionally be aware of strategies such as adaptive randomisation to facilitate allocation into such designs.
- LO5. Understand the different types of trial endpoints (composite, co-primary and surrogate) and the key issues associated with each.
- LO6. Understand the role of the Independent Safety and Data Monitoring Committee and the statistical and ethical issues when monitoring accumulating data from clinical trials.
- LO7. Understand the key principles involved in substudy design and implementation.
Unit availability
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Modes of attendance (MoA)
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