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

被引：0
|
作者：
Luo, Xiaodong [1 ]
Quan, Hui [1 ]
机构：
[1] Sanofi US, Biostat & Programming, 55 Corp Dr, Bridgewater, NJ 08807 USA
来源：
STATISTICS IN BIOPHARMACEUTICAL RESEARCH | 2024年 / 16卷 / 01期
关键词：
Generalized Simes inequality; Group-sequential p-values; Multiplicity; q-values; early submission; alpha-propagation; BONFERRONI PROCEDURE; TESTS;
D O I：
10.1080/19466315.2023.2191989
中图分类号：
Q [生物科学];
学科分类号：
07 ; 0710 ; 09 ;
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.
引用
收藏
页码：104 / 115
页数：12
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