This course builds on a basic course in sample-size calculations such as the one provided by the ICH, and provides an overview of the underlying statistical theory for sample size calculations within the hypothesis testing framework. It addresses practical issues and statistical considerations when calculating sample sizes for a wide range of advanced trial designs and outcome distributions, including factorial, non-inferiority, DURATIONS, group sequential, and clustered randomised clinical trials. It uses real advanced trial examples to calculate the sample size using the available user-written software in both R and Stata. 

Those working on trials and study designs, which includes trialists, trial statisticians, clinicians and other scientists. Familiarity with the hypothesis testing framework (i.e., type I error rate, power, and various effect sizes) are essential. Familiarity with sample size calculation for simple/basic designs is desirable but not essential.