Closed Testing Procedures for Group Sequential Clinical Trials with Multiple Endpoints

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Abstract

Summary. A simple approach is given for conducting closed testing in clinical trials with multiple end-points in which group sequential monitoring is planned. The approach allows a flexible stopping time; the earliest and latest stopping times are described. The paradigm is applicable both to clinical trials with multiple endpoints and to the one-sided multiple comparison problem of several treatments versus a control. The approach leads to enhancements of previous methods and suggestions for new methods. An example of a respiratory disease trial with four endpoints is given.

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