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Sample size calculation for clustered survival data under subunit randomization

Author

Listed:
  • Jianghao Li

    (Duke University)

  • Sin-Ho Jung

    (Duke University)

Abstract

Each cluster consists of multiple subunits from which outcome data are collected. In a subunit randomization trial, subunits are randomized into different intervention arms. Observations from subunits within each cluster tend to be positively correlated due to the shared common frailties, so that the outcome data from a subunit randomization trial have dependency between arms as well as within each arm. For subunit randomization trials with a survival endpoint, few methods have been proposed for sample size calculation showing the clear relationship between the joint survival distribution between subunits and the sample size, especially when the number of subunits from each cluster is variable. In this paper, we propose a closed form sample size formula for weighted rank test to compare the marginal survival distributions between intervention arms under subunit randomization, possibly with variable number of subunits among clusters. We conduct extensive simulations to evaluate the performance of our formula under various design settings, and demonstrate our sample size calculation method with some real clinical trials.

Suggested Citation

  • Jianghao Li & Sin-Ho Jung, 2022. "Sample size calculation for clustered survival data under subunit randomization," Lifetime Data Analysis: An International Journal Devoted to Statistical Methods and Applications for Time-to-Event Data, Springer, vol. 28(1), pages 40-67, January.
    • Handle: RePEc:spr:lifeda:v:28:y:2022:i:1:d:10.1007_s10985-021-09538-0
    DOI: 10.1007/s10985-021-09538-0
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    References listed on IDEAS

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    1. Pals, S.L. & Murray, D.M. & Alfano, C.M. & Shadish, W.R. & Hannan, P.J. & Baker, W.L., 2008. "Individually randomized group treatment trials: A critical appraisal of frequently used design and analytic approaches," American Journal of Public Health, American Public Health Association, vol. 98(8), pages 1418-1424.
    2. Ronald E. Gangnon, 2004. "Sample-size formula for clustered survival data using weighted log-rank statistics," Biometrika, Biometrika Trust, vol. 91(2), pages 263-275, June.
    3. Pals, S.L. & Murray, D.M. & Alfano, C.M. & Shadish, W.R. & Hannan, P.J. & Baker, W.L., 2008. "Individually randomized group treatment trials: A critical appraisal of frequently used design and analytic approaches (American Journal of Public Health (2008) 98 (1418-1424) doi 10.2105/AJPH.2007/12," American Journal of Public Health, American Public Health Association, vol. 98(12), pages 2120-2120.
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    Cited by:

    1. Lu Mao, 2023. "Study design for restricted mean time analysis of recurrent events and death," Biometrics, The International Biometric Society, vol. 79(4), pages 3701-3714, December.

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