BIOSTATS 6013EX - Advanced Clinical Trials

External - Semester 2 - 2014

This elective unit extends and enhances the concepts developed in Design of Experiments and Randomised Controlled Trials. On completion, students have the knowledge and skills required at an advanced professional level to design and analyse clinical trials, including cross-over designs and equivalence trials, and to identify and implement statistical methods for monitoring and reporting, with appropriate knowledge of regulatory requirements. Topics to be covered include: methods in RCTs for determining stopping rules for interim analyses (O'Brien-Fleming, Peto), spending functions, stochastic curtailment; statistical principles encountered in relation to aspects of regulatory guidelines (ICH, HAD, EMEA), and related to reports prepared for data safety and monitoring committees (DSMC); design and analysis of cross-over trials (period effects, interactions); equivalence and non-inferiority trials; and problems of defining and using surrogate endpoints as alternatives to direct clinical outcomes.

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