Department of Mathematics and Statistics, Villanova University, Villanova, PA, USA.
J Biopharm Stat. 2024 Jan 2;34(1):90-110. doi: 10.1080/10543406.2023.2171428. Epub 2023 Feb 9.
The graphical approach has been proposed as a general framework for clinical trial designs involving multiple hypotheses, where decisions are made only based on the observed marginal -values. The graphical approach starts from a graph that includes all hypotheses as vertices and gradually removes some vertices when their corresponding hypotheses are rejected. In this paper, we propose a reverse graphical approach, which starts from a set of singleton graphs and gradually adds vertices into graphs until rejection of a set of hypotheses is made. Proofs of familywise error rate control are provided. A simulation study is conducted for statistical power analysis, and a case study is included to illustrate how the proposed approach can be applied to clinical studies.
图形方法被提出作为一个一般框架用于涉及多个假设的临床试验设计,其中决策仅基于观察到的边缘值作出。图形方法从一个包含所有假设作为顶点的图开始,当相应的假设被拒绝时,逐渐删除一些顶点。在本文中,我们提出了一种反向图形方法,它从一组单顶点图开始,并逐渐向图中添加顶点,直到拒绝一组假设。提供了组错误率控制的证明。进行了模拟研究进行统计功效分析,并包括一个案例研究来说明如何将提出的方法应用于临床研究。