Adaptive sample size calculations in group sequential trials
Adaptive sample size calculations in group sequential trials
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DOI：
10.1111/j.0006-341x.1999.01286.x
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发表时间：
1999-12-01
期刊：
影响因子：
1.9
通讯作者：
Wassmer, G
中科院分区：
文献类型：
--
作者：
Lehmacher, W;Wassmer, G
提出了一种基于逆正态法组合各阶段结果的组序试验方法。在不夸大I型错误率的情况下，该方法可以在研究过程中对数据驱动的样本量进行重新评估。它使用经典群序列检验的停止边界。此外，精确的测试程序可以得到广泛的应用。在功率和期望样本量方面，将该程序与经典设计进行了比较。
A method for group sequential trials that is based on the inverse normal method for combining the results of the separate stages is proposed. Without exaggerating the Type I error rate, this method enables data-driven sample size reassessments during the course of the study. It uses the stopping boundaries of the classical group sequential tests. Furthermore, exact test procedures may be derived for a wide range of applications. The procedure is compared with the classical designs in terms of power and expected sample size.