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群组序贯设计中多重检验的扩展框架。

An Extended Framework of Multiple Testing in Group Sequential Design.

机构信息

Data and Statistical Sciences, AbbVie Inc, North Chicago, IL, 60064, USA.

BeiGene, Ltd., Ridgefield Park, NJ, 07660, USA.

出版信息

Ther Innov Regul Sci. 2023 Jul;57(4):662-670. doi: 10.1007/s43441-023-00507-3. Epub 2023 Mar 16.

Abstract

Here, we consider testing multiple hypotheses in group sequential trials. A graphical multiple test procedure was proposed for group sequential trials using weighted Bonferroni test. In this paper, we extend the framework for the graph-based group sequential procedure by applying a modified weighted Simes test. The proposed procedure preserves the familywise error rate. Simulations are conducted to evaluate the performances of the proposed procedure. The proposed procedures are also illustrated with a numerical example.

摘要

在这里,我们考虑在群组序贯试验中检验多个假设。提出了一种使用加权 Bonferroni 检验的群组序贯试验的图形多重检验程序。在本文中,我们通过应用修改后的加权 Simes 检验来扩展基于图形的群组序贯程序的框架。所提出的程序保留了总体错误率。进行了模拟以评估所提出程序的性能。还通过数值示例说明了所提出的程序。

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