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

Patrick Royston () and Abdel Babiker ()
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Patrick Royston: MRC Clinical Trials Unit, London, UK
Abdel Babiker: MRC Clinical Trials Unit, London, UK

Stata Journal, 2002, vol. 2, issue 2, 151-163

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.

Keywords: randomized controlled trials; survival analysis; logrank test; experimental design (search for similar items in EconPapers)
Date: 2002
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Citations: View citations in EconPapers (4)

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