Some Multiplicity Adjustment Procedures for Clinical Trials with Sequential Design and Multiple Endpoints

This article proposes some new multiplicity adjustment procedures for clinical trials with multiple endpoints and multiple interim analyses. The proposed sequential procedures, adapting the popular multiple comparison procedures for fixed time-point design and using a-spending for each endpoint, are shown to strongly control the family-wise Type-1 error rate and provide powerful yet versatile multiplicity adjustment solutions for monitoring multiple endpoints via interim analyses.

Automated summary

This article proposes new multiplicity adjustment procedures for clinical trials with multiple endpoints and interim analyses. The sequential procedures adapt popular multiple comparison procedures for fixed time-point design and use a-spending for each endpoint. These procedures control the family-wise Type-1 error rate and provide versatile solutions for monitoring multiple endpoints through interim analyses.