Testing and estimation in flexible group sequential designs with adaptive treatment selection

被引:155
作者
Posch, M
Koenig, F
Branson, M
Brannath, W
Dunger-Baldauf, C
Bauer, P
机构
[1] Med Univ Vienna, Sect Med Stat, Core Unit Med Stat & Informat, A-1090 Vienna, Austria
[2] Novartis Pharma AG, Biostat & Stat Reporting, CH-4002 Basel, Switzerland
关键词
treatment selection; simultaneous confidence intervals; flexible designs; clinical trials;
D O I
10.1002/sim.2389
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Integrating selection and confirmation phases into a single trial can expedite the development of new treatments and allows to use all accumulated data in the decision process. In this paper we review adaptive treatment selection based on combination tests and propose overall adjusted p-values and simultaneous confidence intervals. Also point estimation in adaptive trials is considered. The methodology is illustrated in a detailed example based on an actual planned study. Copyright (c) 2005 John Wiley & Sons, Ltd.
引用
收藏
页码:3697 / 3714
页数:18
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