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EPM5016 - Advanced clinical trials

6 points, SCA Band 2, 0.125 EFTSL

Postgraduate Faculty of Medicine, Nursing and Health Sciences


Alfred Hospital Second semester 2008 (Off-campus)


This unit involves advanced topics in the design and analysis of randomized clinical trials.


On completion of this unit, students should be able to:

  1. Formulate an interim analysis plan for randomised trial and perform the corresponding specialized analyses;
  2. Demonstrate knowledge of the regulatory issues and principles underlying the conduct of any clinical trial;
  3. Understand and explain the basis for cross-over trials, their advantages and their pitfalls together with analysis methodology for such trials;
  4. Understand and apply the principles underpinning equivalence and non-inferiority trials
  5. 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).


EPM5002, EPM5003, EPM5004

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