A generalized Dunnett test for multi-arm multi-stage clinical studies with treatment selection
A generalized Dunnett test for multi-arm multi-stage clinical studies with treatment selection
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DOI：
10.1093/biomet/ass002
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发表时间：
2012-06-01
期刊：
影响因子：
2.7
通讯作者：
Whitehead, J.
中科院分区：
文献类型：
--
作者：
Magirr, D.;Jaki, T.;Whitehead, J.
我们推广了Dunnett检验，得出了具有已知方差的正态分布终点的灵活多臂多阶段临床试验的有效性和无效性边界。我们证明了边界在强意义上控制着FAMIYWISE错误率。该方法适用于任意数量的治疗臂、阶段数和每个阶段每个治疗的患者数量。它可用于从阿尔法支出函数派生的各种边界类型或规则。此外，我们还展示了如何在最不有利的配置功率要求下计算样本量，并推导出预期样本量的公式。
We generalize the Dunnett test to derive efficacy and futility boundaries for a flexible multi-arm multi-stage clinical trial for a normally distributed endpoint with known variance. We show that the boundaries control the familywise error rate in the strong sense. The method is applicable for any number of treatment arms, number of stages and number of patients per treatment per stage. It can be used for a wide variety of boundary types or rules derived from alpha-spending functions. Additionally, we show how sample size can be computed under a least favourable configuration power requirement and derive formulae for expected sample sizes.