Adaptive Dunnett tests for treatment selection
Adaptive Dunnett tests for treatment selection
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DOI：
10.1002/sim.3048
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发表时间：
2008-05-10
影响因子：
2
通讯作者：
Posch, Martin
中科院分区：
文献类型：
--
作者：
Koenig, Franz;Brannath, Werner;Posch, Martin
在预先指定的中期分析中纳入治疗选择的临床试验允许将两项临床研究整合到单个验证性研究中。在适应性中期分析中，根据中期数据以及外部信息选择治疗组。具体的选择规则不需要为了控制多个I类错误率而提前预先指定。基于单阶段Dunnett检验的条件错误率，提出了一种自适应Dunnett检验方法。自适应程序统一改进经典的Dunnett检验，这是严格保守的，如果治疗在中期下降。自适应Dunnett检验与经典Dunnett检验以及基于封闭原理的自适应组合检验进行了仿真比较。该方法是用一个实际数据的例子来说明。版权所有（C）2007约翰威利父子有限公司
Clinical trials incorporating treatment selection at pre-specified interim analyses allow to integrate two clinical studies into a single, confirmatory study. In an adaptive interim analysis, treatment arms are selected based on interim data as well as external information. The specific selection rule does not need to be pre-specified in advance in order to control the multiple type I error rate. We propose an adaptive Dunnett test procedure based on the conditional error rate of the single-stage Dunnett test. The adaptive procedure uniformly improves the classical Dunnett test, which is shown to be strictly conservative if treatments are dropped at interim. The adaptive Dunnett test is compared in a simulation with the classical Dunnett test as well as with adaptive combination tests based on the closure principle. The method is illustrated with a real-data example. Copyright (C) 2007 John Wiley & Sons, Ltd.