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Sample-size formula for clustered survival data using weighted log-rank statistics

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  • Ronald E. Gangnon

Abstract

We present a simple sample-size formula for weighted log-rank statistics applied to clustered survival data with variable cluster sizes and arbitrary treatment assignments within clusters. This formula is based on the asymptotic normality of weighted log-rank statistics under certain local alternatives in the clustered data context. We also provide consistent variance estimators. The derived sample-size formula reduces to Schoenfeld's (1983) formula for cases of no clustering or independence within clusters. Simulation results verify control of the Type I error and accuracy of the sample-size formula. Use of the sample-size formula in an event-driven clinical trial design is illustrated using data from the Early Treatment Diabetic Retinopathy Study. Copyright Biometrika Trust 2004, Oxford University Press.

Suggested Citation

  • 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.
    • Handle: RePEc:oup:biomet:v:91:y:2004:i:2:p:263-275
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    Cited by:

    1. 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.
    2. Tokola, K. & Larocque, D. & Nevalainen, J. & Oja, H., 2011. "Power, sample size and sampling costs for clustered data," Statistics & Probability Letters, Elsevier, vol. 81(7), pages 852-860, July.
    3. Rui Song & Michael R. Kosorok & Jianwen Cai, 2008. "Robust Covariate‐Adjusted Log‐Rank Statistics and Corresponding Sample Size Formula for Recurrent Events Data," Biometrics, The International Biometric Society, vol. 64(3), pages 741-750, September.
    4. Casper T. Charles & Cook Thomas D., 2012. "Estimation of the Mean Frequency Function for Recurrent Events when Ascertainment of Events Is Delayed," The International Journal of Biostatistics, De Gruyter, vol. 8(1), pages 1-20, February.
    5. Su, Pei-Fang & Li, Chung-I & Shyr, Yu, 2014. "Sample size determination for paired right-censored data based on the difference of Kaplan–Meier estimates," Computational Statistics & Data Analysis, Elsevier, vol. 74(C), pages 39-51.
    6. Kosorok, Michael R. & Gangnon, Ronald E., 2006. "Resolving the tail instability in weighted log-rank statistics for clustered survival data," Statistics & Probability Letters, Elsevier, vol. 76(3), pages 304-309, February.
    7. Micha Mandel & Rebecca A. Betensky, 2007. "Testing Goodness of Fit of a Uniform Truncation Model," Biometrics, The International Biometric Society, vol. 63(2), pages 405-412, June.

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