Interim treatment selection in drug development

被引：2

作者：

Li G. ^{[1
]}

Wang Y. ^{[1
]}

Ouyang S.P. ^{[2
]}

机构：

[1] Johnson and Johnson, Pharmaceutical RandD, LLC, Raritan, NJ 08869, 920 Route 202

[2] Celgene Corporation, Summit, NJ 07901

来源：

Statistics in Biosciences | 2009年 / 1卷 / 2期

关键词：

Clinical trial; Closure principle; Family-wise error rate; Interim treatment selection; Multiple comparison; Step-down approach;

D O I：

10.1007/s12561-009-9017-y

中图分类号：

学科分类号：

摘要：

We consider hypothesis testing in a clinical trial with an interim treatment selection. Recently, unconditional and conditional procedures for selecting one treatment as the winner have been proposed when the mean responses are approximately normal. In this paper, we generalize both procedures to multi-winner cases. The distributions of the test statistics are obtained and step-down approaches are proposed. We prove that both unconditional and conditional procedures strongly control the family-wise error rate. We give a brief discussion on power comparisons. © International Chinese Statistical Association 2009.

引用

页码：268 / 288

页数：20

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