Group-sequential logrank methods for trial designs using bivariate non-competing event-time outcomes.

ABSTRACT: We discuss the multivariate (2L-variate) correlation structure and the asymptotic distribution for the group-sequential weighted logrank statistics formulated when monitoring two correlated event-time outcomes in clinical trials. The asymptotic distribution and the variance-covariance for the 2L-variate weighted logrank statistic are derived as available in various group-sequential trial designs. These methods are used to determine a group-sequential testing procedure based on calendar times or information fractions. We apply the theoretical results to a group-sequential method for monitoring a clinical trial with early stopping for efficacy when the trial is designed to evaluate the joint effect on two correlated event-time outcomes. We illustrate the method with application to a clinical

SUBMITTER: Sugimoto T 

PROVIDER: S-EPMC7517875 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature