A group sequential Holm procedure with multiple primary endpoints

被引:39
作者
Ye, Yining [1 ]
Li, Ai [2 ]
Liu, Lingyun [3 ]
Yao, Bin [2 ]
机构
[1] Amgen Inc, Global Biostat Sci, San Francisco, CA USA
[2] Amgen Inc, Global Biostat Sci, Thousand Oaks, CA 91320 USA
[3] Cytel Corp, Cambridge, MA USA
关键词
multiplicity adjustment; multiple endpoints; group sequential designs; Holm procedure; familywise type I error rate; CLOSED TESTING PROCEDURES; CELL LUNG-CANCER; FIXED-SEQUENCE; BONFERRONI PROCEDURE;
D O I
10.1002/sim.5700
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
We propose a group sequential Holm procedure when there are multiple primary endpoints. This method addresses multiplicities arising from multiple primary endpoints and from multiple analyses in a group sequential design. It has been shown to be a closed testing procedure and preserves the familywise error rate in the strong sense. When multiple endpoints are the only concern without an interim analysis, the method simplifies to the weighted Holm procedure. The proposed method is more powerful than the parallel group sequential method and avoids the need to anticipate the testing order as in the fixed sequence testing scheme. Copyright (c) 2012 John Wiley & Sons, Ltd.
引用
收藏
页码:1112 / 1124
页数:13
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