- Adaptive Design with Coprimary Endpoints
Mark Chang · 2014
In a clinical trial with multiple coprimary endpoints, the efficacy require- ment is defined as meeting two or more endpoints simultaneously. There- fore, in an adaptive design of multiple endpoint trial, we have to deal with the multiplicity due to multiple endpoints and multiple analyses at differ- ent times. We will use mathematical induction to prove that the stopping boundaries from group sequential stopping boundaries with a single end- point can be use directly without inflation or deflation the type-I error. We will also derive the formulations for conditional power and power for group sequential design with multiple endpoints, which is an extension of the con- ditional power for single endpoint developed by Lan and Wittes (1988). The extension of the method to sample-size reestimation design is also provided with illustrative examples (Cheng, 2014; Cheng, Menon, and Chang, 2014). 13.1 Introduction