Gatekekeeping procedures with clinical trial applications

Gatekekeeping procedures with clinical trial applications
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DOI:
10.1002/pst.291
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发表时间:
2007-07-01
影响因子:
1.5
通讯作者:
Tamhane, Ajit C.
Tamhane, Ajit C.
中科院分区:
医学4区
文献类型:
--
作者:
Dmitrienko, Alex;Tamhane, Ajit C.

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本文的目的是概述一个相对较新的多样性研究领域,该领域涉及对分层排序的多个目标的分析。针对这一问题的测试程序被称为把关程序,并在临床试验中得到了各种应用。本文回顾了这些过程的主要类别,包括串行和并行门控过程,以及考虑多个目标之间的逻辑限制的树门控过程。我们专注于基于边际p值的过程;还注意到利用p值的联合分布的过程的扩展。临床试验的例子被用来说明程序和它们的重要性质。版权所有(C)2007 John Wiley&Sons,Ltd.
The objective of this paper is to give an overview of a relatively new area of multiplicity research that deals with the analysis of hierarchically ordered multiple objectives. Testing procedures for this problem are known as gatekeeping procedures and have found a variety of applications in clinical trials. This paper reviews main classes of these procedures, including serial and parallel gatekeeping procedures, and tree gatekeeping procedures that account for logical restrictions among multiple objectives. We focus on procedures based on marginal p-values; extensions to procedures that exploit the joint distribution of the p-values are also noted. Clinical trial examples are used to illustrate the procedures and their important properties. Copyright (C) 2007 John Wiley & Sons, Ltd.