A Statistical Framework for Decision Making in Confirmatory Multipopulation Tailoring Clinical Trials
A Statistical Framework for Decision Making in Confirmatory Multipopulation Tailoring Clinical Trials
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DOI：
10.1177/0092861512454116
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发表时间：
2012-11-01
影响因子：
--
通讯作者：
Shen, Lei
中科院分区：
文献类型：
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作者：
Millen, Brian A.;Dmitrienko, Alex;Shen, Lei
本文侧重于对追求量身定制治疗目标的临床试验进行统计分析，其中治疗效果的评估既发生在总体人群中，也发生在预定义的亚人群中。提出的设计和分析原则为基于这些新颖的多群体剪裁试验设计的决策提供了一个框架，考虑到验证性试验的特殊情况。这些原则包括传统的多重测试考虑，以及两个新的分析原则。
This article focuses on statistical analysis of clinical trials pursuing tailored therapy objectives, wherein evaluation of treatment effect occurs in the overall population as well as in a predefined subpopulation(s). The design and analysis principles presented provide a framework for decision making based on these novel multipopulation tailoring trial designs, considering the particular case of confirmatory trials. These principles include traditional multiple testing considerations, as well as 2 new analysis principles.