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A logrank test-based method for sizing clinical trials with two co-primary time-to-event endpoints

Authors :
Takashi Sozu
Tomoyuki Sugimoto
Scott R. Evans
Toshimitsu Hamasaki
Source :
Biostatistics. 14:409-421
Publication Year :
2013
Publisher :
Oxford University Press (OUP), 2013.

Abstract

We discuss sample size determination for clinical trials evaluating the joint effects of an intervention on two potentially correlated co-primary time-to-event endpoints. For illustration, we consider the most common case, a comparison of two randomized groups, and use typical copula families to model the bivariate endpoints. A correlation structure of the bivariate logrank statistic is specified to account for the correlation among the endpoints, although the between-group comparison is performed using the univariate logrank statistic. We propose methods to calculate the required sample size to compare the two groups and evaluate the performance of the methods and the behavior of required sample sizes via simulation.

Details

ISSN :
14684357 and 14654644
Volume :
14
Database :
OpenAIRE
Journal :
Biostatistics
Accession number :
edsair.doi.dedup.....9d6de4dae932ad6b8c0d4342bf8d2e4e
Full Text :
https://doi.org/10.1093/biostatistics/kxs057