Testing secondary hypotheses following sequential clinical trials

Citation
A. Liu et al., Testing secondary hypotheses following sequential clinical trials, BIOMETRICS, 56(2), 2000, pp. 640-644
Citations number
21
Categorie Soggetti
Biology,Multidisciplinary
Journal title
BIOMETRICS
ISSN journal
0006341X → ACNP
Volume
56
Issue
2
Year of publication
2000
Pages
640 - 644
Database
ISI
SICI code
0006-341X(200006)56:2<640:TSHFSC>2.0.ZU;2-V
Abstract
Sequential monitoring in a clinical trial poses difficulty in hypotheses te sting on secondary endpoints after the trial is terminated. The conventiona l likelihood-based testing procedure that ignores the sequential monitoring inflates Type I error and undermines power. In this article, we show that the power of the conventional testing procedure can be substantially improv ed while the Type I error is controlled. Thr method is illustrated with a r eal clinical trial.