A menu-driven facility for sample-size calculation in multiarm, multistage randomized controlled trials with time-to-event outcomes: Update
Daniel J. Bratton
MRC Clinical Trials Unit
University College London
London, UK
[email protected]
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Babak Choodari-Oskooei
MRC Clinical Trials Unit
University College London
London, UK
[email protected]
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Patrick Royston
MRC Clinical Trials Unit
University College London
London, UK
[email protected]
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Abstract. Barthel, Royston, and Parmar (2009, Stata Journal 9: 505–523)
presented a menu-driven Stata program for calculating sample size and other
design characteristics for a class of multiarm, multistage trials with
time-to-event outcomes. In this article, we present several new features for
the package. First, we allow hazard ratios greater than 1 to be targeted under
the alternative hypothesis to make the design more widely applicable to other
outcomes and disease areas. Second, we introduce new subroutines that use
simulation to more accurately estimate the correlation between treatment
effects at different stages and that calculate the familywise error rate, and
we apply them to an example using the original design of the multiarm,
multistage trial in prostate cancer. Finally, we present a new design of the
dialog menu for nstage that improves its usability and incorporates
options for calling the new subroutines.
View all articles by these authors:
Daniel J. Bratton, Babak Choodari-Oskooei, Patrick Royston
View all articles with these keywords:
nstage, nstagemenu, multiarm, multistage, randomized controlled trial, survival analysis, time-to-event, familywise error rate
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