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

Autor:	Sugimoto, Tomoyuki, Hamasaki, Toshimitsu, Evans, Scott R., Halabi, Susan
Předmět:	CLINICAL trials monitoring ASYMPTOTIC distribution LOG-rank test BIVARIATE analysis CLINICAL trials EXPERIMENTAL design RESEARCH RESEARCH methodology MEDICAL cooperation EVALUATION research COMPARATIVE studies RESEARCH funding STATISTICAL models ALGORITHMS
Zdroj:	Lifetime Data Analysis; Apr2020, Vol. 26 Issue 2, p266-291, 26p
Abstrakt:	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 trial and describe how to calculate the required sample sizes and numbers of events. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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