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Design and analysis of clinical trials in the presence of delayed treatment effect.
- Source :
-
Statistics in Medicine . May2016, Vol. 35 Issue 11, p1774-1779. 6p. - Publication Year :
- 2016
-
Abstract
- In clinical trials with survival endpoint, it is common to observe an overlap between two Kaplan-Meier curves of treatment and control groups during the early stage of the trials, indicating a potential delayed treatment effect. Formulas have been derived for the asymptotic power of the log-rank test in the presence of delayed treatment effect and its accompanying sample size calculation. In this paper, we first reformulate the alternative hypothesis with the delayed treatment effect in a rescaled time domain, which can yield a simplified sample size formula for the log-rank test in this context. We further propose an intersection-union test to examine the efficacy of treatment with delayed effect and show it to be more powerful than the log-rank test. Simulation studies are conducted to demonstrate the proposed methods. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 02776715
- Volume :
- 35
- Issue :
- 11
- Database :
- Academic Search Index
- Journal :
- Statistics in Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 114436676
- Full Text :
- https://doi.org/10.1002/sim.6889