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

Author

Listed:
  • Tomoyuki Sugimoto

    (Shiga University)

  • Toshimitsu Hamasaki

    (National Cerebral and Cardiovascular Center)

  • Scott R. Evans

    (George Washington University)

  • Susan Halabi

    (Duke University School of Medicine)

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 trial and describe how to calculate the required sample sizes and numbers of events.

Suggested Citation

  • Tomoyuki Sugimoto & Toshimitsu Hamasaki & Scott R. Evans & Susan Halabi, 2020. "Group-sequential logrank methods for trial designs using bivariate non-competing event-time outcomes," Lifetime Data Analysis: An International Journal Devoted to Statistical Methods and Applications for Time-to-Event Data, Springer, vol. 26(2), pages 266-291, April.
    • Handle: RePEc:spr:lifeda:v:26:y:2020:i:2:d:10.1007_s10985-019-09470-4
    DOI: 10.1007/s10985-019-09470-4
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    References listed on IDEAS

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    1. Adin-Cristian Andrei & Susan Murray, 2005. "Simultaneous Group Sequential Analysis of Rank-Based and Weighted Kaplan–Meier Tests for Paired Censored Survival Data," Biometrics, The International Biometric Society, vol. 61(3), pages 715-720, September.
    2. Michael R. Kosorok & Shi Yuanjun & David L. DeMets, 2004. "Design and Analysis of Group Sequential Clinical Trials with Multiple Primary Endpoints," Biometrics, The International Biometric Society, vol. 60(1), pages 134-145, March.
    3. Susan Murray, 2000. "Nonparametric Rank-Based Methods for Group Sequential Monitoring of Paired Censored Survival Data," Biometrics, The International Biometric Society, vol. 56(4), pages 984-990, December.
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