Design of Group Sequential Clinical Trials with Multiple Endpoints

Abstract

Abstract Group sequential testing for randomized clinical trials designed with multiple endpoints is considered. Previously computed tables for single endpoints are still useful, with a change in interpretation of certain parameters. The advantage in setting sample size based on multiple endpoints is that the sample size required when a trial is designed using more than one endpoint is smaller than the sample size based on any single endpoint, if the two calculations are undertaken using matching significance levels and powers. An example is provided, and possible extensions of the work are discussed.