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A menu-driven facility for complex sample size calculation in randomized controlled trials with a survival or a binary outcome

Author

Listed:
  • Patrick Royston

    (MRC Clinical Trials Unit, London, UK)

  • Abdel Babiker

    (MRC Clinical Trials Unit, London, UK)

Abstract

We present a menu-driven Stata program for the calculation of sample size or power for complex clinical trials with a survival time or a binary outcome. The features supported include up to six treatment arms, an arbitrary time-to- event distribution, fixed or time-varying hazard ratios, unequal patient allocation, loss to follow-up, staggered patient entry,and crossover of patients from their allocated treatment to an alternative treatment. The computations of sample size and power are based on the logrank test and are done according to the asymptotic distribution of the logrank test statistic, adjusted appropriately for the design features. Copyright 2002 by Stata Corporation.

Suggested Citation

  • Patrick Royston & Abdel Babiker, 2002. "A menu-driven facility for complex sample size calculation in randomized controlled trials with a survival or a binary outcome," Stata Journal, StataCorp LP, vol. 2(2), pages 151-163, May.
    • Handle: RePEc:tsj:stataj:v:2:y:2002:i:2:p:151-163
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    Citations

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    Cited by:

    1. Karla Hemming & Jen Marsh, 2013. "A menu-driven facility for sample-size calculations in cluster randomized controlled trials," Stata Journal, StataCorp LP, vol. 13(1), pages 114-135, March.
    2. Friederike M.-S. Barthel & Patrick Royston & Abdel Babiker, 2005. "A menu-driven facility for complex sample size calculation in randomized controlled trials with a survival or a binary outcome: Update," Stata Journal, StataCorp LP, vol. 5(1), pages 123-129, March.
    3. Li Liu & Mengying Li & Li Yang & Lirong Ju & Biqin Tan & Neff Walker & Jennifer Bryce & Harry Campbell & Robert E Black & Yan Guo, 2013. "Measuring Coverage in MNCH: A Validation Study Linking Population Survey Derived Coverage to Maternal, Newborn, and Child Health Care Records in Rural China," PLOS ONE, Public Library of Science, vol. 8(5), pages 1-10, May.
    4. H. Joseph Newton & Nicholas J. Cox, 2016. "The Stata Journal Editors' Prize 2016: Patrick Royston," Stata Journal, StataCorp LP, vol. 16(4), pages 815-825, December.

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