Postgraduate - UnitEPM5016 - Advanced clinical trials

This unit entry is for students who completed this unit in 2014 only. For students planning to study the unit, please refer to the unit indexes in the the current edition of the Handbook. If you have any queries contact the managing faculty for your course or area of study.

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6 points, SCA Band 2, 0.125 EFTSL

Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered, or view unit timetables.

Level	Postgraduate
Faculty	Faculty of Medicine, Nursing and Health Sciences
Organisational Unit	Department of Epidemiology and Preventive Medicine
Offered	Alfred Hospital Second semester 2014 (Off-campus)
Coordinator(s)	Professor V Gebski

Synopsis

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.

Outcomes

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.