Monash University Handbook 2010 Postgraduate - Unit

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.

Objectives

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.

Assessment

Four written assignments (worth 25%, 25%, 10%, 40% respectively).

Chief examiner(s)

Associate Professor V Gebski

Prerequisites

EPM5002, EPM5003, EPM5004, EPM5007, EPM5014, MPH1040.

Prohibitions

This unit is only available to students enrolled in the Graduate Certificate, Graduate Diploma or Masters of Biostatistics.

Additional information on this unit is available from the faculty at:

http://www.med.monash.edu.au/epidemiology/pgrad