Journal
CONTEMPORARY CLINICAL TRIALS
Volume 101, Issue -, Pages -Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2020.106244
Keywords
Bonferroni-Holm procedure; Conjunctive power; Disjunctive power; Fixed-sequence procedure; Logrank test; Pocock-type boundary function
Funding
- National Institute of Allergy and Infectious Diseases of the National Institutes of Health [UM1AI104681]
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The study investigated the selection of critical boundary functions for testing hypotheses of two time-to-event outcomes in group-sequential clinical trials. It considered unequal effect sizes of endpoints and different evaluation periods for the endpoints. The effects of hazard ratios magnitudes and correlation between endpoints on statistical powers were assessed to provide guidance for consideration.
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 longterm 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.
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