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.
Reference Type
Journal Article
Periodical Full
Contemporary clinical trials
Publication Year
2021
Publication Date
Feb
Volume
101
Start Page
106244
Publisher
Elsevier Inc
Place of Publication
United States
ISSN/ISBN
1551-7144
Document Object Index
10.1016/j.cct.2020.106244
URL
https://dx.doi.org/10.1016/j.cct.2020.106244
PMID
33309946