Gatekeeping Procedure in Confirmatory Clinical Trials

Abstract

In confirmatory clinical trials, family wise error rate (FWER) must be controlled in the strong sense. Gatekeeping procedure are widely used in clinical trials to adjust for hypothesis testing problems with a hierarchical structure. This approach ensures FWER control in the strong sense, because of the algorithm for constructing the gatekeeping procedure based on the closed testing principle. In this article, we present an overview of the gatekeeping procedure and current practice in the use of the approach.