EPM5016 - Advanced clinical trials
6 points, SCA Band 2, 0.125 EFTSL
Postgraduate Faculty of Medicine, Nursing and Health Sciences
Leader(s): A/Prof V Gebski
Alfred Hospital Second semester 2009 (Off-campus)
This unit introduces advanced methods used in clinical research & clinical trials in particular. Group sequential methods are introduced as a mechanism for allowing investigators to perform interim analyses while the data is accumulating without compromising the scientific & statistical validly of the study. Regulatory guidelines for conduct & reporting of clinical trials are presented & discussed in detail. More advanced designs than the simple parallel-group randomized trial to assess superiority are presented, namely crossover, equivalence & non-inferiority trials. Finally an introduction to problems of defining & using surrogate endpoints as substitutes for direct clinical outcomes will be provided, including definitions, statistical properties & examples.
On completion of this unit, students should be able to:
- Formulate an interim analysis plan for randomised trial and perform the corresponding specialized analyses;
- Demonstrate knowledge of the regulatory issues and principles underlying the conduct of any clinical trial;
- Understand and explain the basis for cross-over trials, their advantages and their pitfalls together with analysis methodology for such trials;
- Understand and apply the principles underpinning equivalence and non-inferiority trials
- Appreciate issue associated with defining and using valid surrogate end points as alternatives to primary clinical end points and apply these in practical settings.
Four written assignments (worth 25%, 25%, 10%, 40% respectively).