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

STATISTICS IN BIOPHARMACEUTICAL RESEARCH(2024)

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摘要
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.
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关键词
Generalized Simes inequality,Group-sequential p-values,Multiplicity,q-values,early submission,alpha-propagation
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