Step-Down Parametric Procedures for Testing Correlated Endpoints in a Group-Sequential Trial

被引:10
作者
Fu, Yiyong [1 ]
机构
[1] TechData Serv Co LLC, 700 Amer Ave,Suite 102, King Of Prussia, PA 19406 USA
来源
STATISTICS IN BIOPHARMACEUTICAL RESEARCH | 2018年 / 10卷 / 01期
关键词
Closure method; Consonant procedure; Family-wise error rate; Group-sequential; Multiple testing procedure; CLINICAL-TRIALS; MULTIPLE;
D O I
10.1080/19466315.2017.1369898
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Maurer and Bretz developed a class of group-sequential weighted Bonferroni procedures with multiple endpoints. Performed as a step-down consonant shortcut to the group-sequential closed testing procedure, the class of procedures of Maurer and Bretz is simple to use for testing multiple endpoints in classical group-sequential settings. This class uses the correlations of sequential statistics, but does not leverage the correlations between endpoints. Thus, there is room for power improvement by suitably using the between-endpoint correlations in a group-sequential trial while maintaining strong control of the family-wise error rate. To this end, we propose a Holm-type step-down exact parametric procedure for situations in which between-endpoint correlations are known a priori or estimable. An adaptive strategy is suggested for situations in which such correlations are unknown. In addition, we briefly discuss a natural group-sequential extension of the partially parametric Seneta-Chen procedure.
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页码:18 / 25
页数:8
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