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... -- Course Website
Instructor: Professor V Gebski
Prerequisites: EPM5002, EPM5003, EPM5004, EPM5007, EPM5014 and MPH5040.
