Evaluating the adaptive performance of flexible sample size designs with treatment difference in an interval
Evaluating the adaptive performance of flexible sample size designs with treatment difference in an interval
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DOI：
10.1002/sim.2998
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发表时间：
2008-02-20
影响因子：
2
通讯作者：
Cui, Lu
中科院分区：
文献类型：
--
作者：
Liu, G. Frank;Zhu, G. Ray;Cui, Lu
在临床试验中，通常选择研究样本量以在治疗差异的单个点提供特定功效。当该治疗差异不接近真实差异时，试验的实际功效可能会偏离指定功效。为了解决这个问题，我们考虑获得一个灵活的样本量设计，提供足够的功效，并在一个区间内的真实治疗差异的可能值上接近“理想”样本量。提出了性能评分来评估这些灵活样本量设计的总体性能。它的应用，以确定最佳的解决方案之间考虑候选样本量设计进行了讨论，并通过计算机模拟说明。版权所有（c）2007约翰威利父子有限公司。
In clinical trials, the study sample size is often chosen to provide specific power at a single point of a treatment difference. When this treatment difference is not close to the true one, the actual power of the trial can deviate from the specified power. To address this issue, we consider obtaining a flexible sample size design that provides sufficient power and has close to the 'ideal' sample size over possible values of the true treatment difference within an interval. A performance score is proposed to assess the overall performance of these flexible sample size designs. Its application to the determination of the best solution among considered candidate sample size designs is discussed and illustrated through computer simulations. Copyright (c) 2007 John Wiley & Sons, Ltd.