A menu–driven facility for complex sample size calculation in randomized controlled trials with a survival or a binary outcome
Patrick Royston
MRC Clinical Trials Unit, London, UK
patrick.royston@ctu.mrc.ac.uk
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Abdel Babiker
MRC Clinical Trials Unit, London, UK
abdel.babiker@ctu.mrc.ac.uk
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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.
View all articles by these authors:
Patrick Royston, Abdel Babiker
View all articles with these keywords:
randomized controlled trials, survival analysis, logrank test, experimental design
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