Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives
Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives
复制标题
具有分层排序多个目标的临床试验中的树形结构把关测试
DOI：
10.1002/sim.2716
复制
发表时间：
2007-05-30
影响因子：
2
通讯作者：
Wang, Xin
中科院分区：
文献类型：
--
作者：
Dmitrienko, Alex;Wiens, Brian L.;Wang, Xin
本文讨论了一类新的多重测试程序--树形结构的把关程序，并结合临床试验应用。这些程序出现在具有分级排序的多个目标的临床试验中，例如，在具有逻辑限制或多个终点分析的多个剂量对照试验的背景下。该方法基于封闭测试的原理，推广了Westfall和Krishen(J.Statist)提出的串联和并行门控方法。计划推断2001；99：25-41)和Dmitrienko等人。(统计学家。地中海医院。2003年；22：2387-2400)。建议的测试方法使用多个终点(一级、二级和三级)和多目标(优势和非劣势测试)的临床试验以及具有多个终点的剂量发现试验来说明。版权所有(C)2006 John Wiley&Sons，Ltd.
This paper discusses a new class of multiple testing procedures, tree-structured gatekeeping procedures, with clinical trial applications. These procedures arise in clinical trials with hierarchically ordered multiple objectives, for example, in the context of multiple dose-control tests with logical restrictions or analysis of multiple endpoints. The proposed approach is based on the principle of closed testing and generalizes the serial and parallel gatekeeping approaches developed by Westfall and Krishen (J. Statist. Planning Infer 2001; 99:25-41) and Dmitrienko et al. (Statist. Med. 2003; 22:2387-2400). The proposed testing methodology is illustrated using a clinical trial with multiple endpoints (primary, secondary and tertiary) and multiple objectives (superiority and non-inferiority testing) as well as a dose-finding trial with multiple endpoints. Copyright (C) 2006 John Wiley & Sons, Ltd.