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

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Sugimoto, T; Hamasaki, T; Evans, SR; Halabi, S

Published Date

  • April 2020

Published In

Volume / Issue

  • 26 / 2

Start / End Page

  • 266 - 291

PubMed ID

  • 30980317

Pubmed Central ID

  • 30980317

Electronic International Standard Serial Number (EISSN)

  • 1572-9249

Digital Object Identifier (DOI)

  • 10.1007/s10985-019-09470-4

Language

  • eng

Conference Location

  • United States