Type I error and power in trials with one interim futility analysis
Type I error and power in trials with one interim futility analysis
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DOI：
10.1002/pst.93
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发表时间：
2004-01-01
影响因子：
1.5
通讯作者：
Chuang-Stein, C
中科院分区：
文献类型：
--
作者：
Chang, WH;Chuang-Stein, C
Futility analysis reduces the opportunity to commit Type I error. For a superiority study testing a two-sided hypothesis, an interim futility analysis can substantially reduce the overall Type I error while keeping the overall power relatively intact. In this paper, we quantify the extent of the reduction for both one-sided and two-sided futility analysis. We argue that, because of the reduction, we should be allowed to set the significance level for the final analysis at a level higher than the allowable Type I error rate for the study. We propose a method to find the significance level for the final analysis. We illustrate the proposed methodology and show that a design employing a futility analysis can reduce the sample size, and therefore reduce the exposure of patients to unnecessary risk and lower the cost of a clinical trial. Copyright (C) 2004 John Wiley Sons Ltd.
