Some comments on frequently used multiple endpoint adjustment methods in clinical trials
Some comments on frequently used multiple endpoint adjustment methods in clinical trials
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DOI：
10.1002/(sici)1097-0258(19971130)16:22
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发表时间：
1997-11-30
影响因子：
2
通讯作者：
Dubey, SD
中科院分区：
文献类型：
--
作者：
Sankoh, AJ;Huque, MF;Dubey, SD
验证性临床试验通常将临床反应变量分为主要终点和次要终点。临床试验中存在两个或更多个主要终点通常意味着可能需要针对多个试验对观察到的p值进行一些调整，以控制类型I错误率。在这篇文章中，我们讨论了与一些常用的多终点调整程序相关的统计问题。我们还给出了有限的蒙特卡罗仿真结果，以演示所选的基于p值的方法在保护I类误码率方面的性能。(C)1997年John Wiley&Sons，Ltd.
Confirmatory clinical trials often classify clinical response variables into primary and secondary endpoints. The presence of two or more primary endpoints in a clinical trial usually means that some adjustments of the observed p-values for multiplicity of tests may be required for the control of the type I error rate. In this paper, we discuss statistical concerns associated with some commonly used multiple endpoint adjustment procedures. We also present limited Monte Carlo simulation results to demonstrate the performance of selected p-value-based methods in protecting the type I error rate. (C) 1997 by John Wiley & Sons, Ltd.