The Biostatistics Center and the Innovations in Design, Education, and Analysis Committee (IDEA), the George Washington University, USA; Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, the George Washington University, USA.
Division of Biometrics I, Office of Biostatistics, OTS/CDER, Food and Drug Administration, USA.
Contemp Clin Trials. 2021 Feb;101:106244. doi: 10.1016/j.cct.2020.106244. Epub 2020 Dec 9.
We investigate selection of critical boundary functions for testing the hypotheses of two time-to-event outcomes as both primary endpoints or a primary and a secondary endpoint in group-sequential clinical trials, where (1) the effect sizes of endpoints are unequal, or (2) one endpoint is for short-term evaluation and the other for long-term evaluation. Bonferroni-Holm and fixed-sequence procedures are considered. We assess the effects of the magnitudes of the hazard ratios and the correlation between the endpoints on statistical powers and provide guidance for consideration.
我们研究了临界边界函数的选择，用于检验群组序贯临床试验中两个事件时间结局作为主要终点或一个主要终点和一个次要终点的假设，其中（1）终点的效应大小不等，或（2）一个终点用于短期评估，另一个用于长期评估。考虑了 Bonferroni-Holm 和固定序列程序。我们评估了危险比的大小和终点之间的相关性对统计功效的影响，并提供了考虑因素的指导。
