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Biostatistics Advance Access originally published online on December 6, 2006
Biostatistics 2007 8(4):689-694; doi:10.1093/biostatistics/kxl040
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© The Author 2006. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org.

The influence of competing-risks setting on the choice of hypothesis test for treatment effect

P. R. Williamson*, R. Kolamunnage-Dona and C. Tudur Smith

Centre for Medical Statistics and Health Evaluation, Shelley's Cottage, Brownlow Street, University of Liverpool, Liverpool L69 3GS, UK p.r.williamson{at}liverpool.ac.uk

* To whom correspondence should be addressed

There is considerable debate regarding the choice of test for treatment difference in a randomized clinical trial in the presence of competing risks. This question arose in the study of standard and new antiepileptic drugs (SANAD) trial comparing new and standard antiepileptic drugs. This paper provides simulation results for the log-rank test comparing cause-specific hazard rates and Gray's test comparing cause-specific cumulative incidence curves. To inform the analysis of the SANAD trial, competing-risks settings were considered where both events are of interest, events may be negatively correlated, and the degree of correlation may differ in the 2 treatment groups. In settings where there are effects in opposite directions for the 2 event types, a likely situation for the SANAD trial, Gray's test has greater power to detect treatment differences than log-rank analysis. For the epilepsy application, conclusions were qualitatively similar for both log-rank and Gray's tests.

Keywords: Anti-epileptic drugs; Competing risks; Cumulative incidence; Hypothesis test; Logrank test

Received July 1, 2006; revised October 13, 2006; revised November 22, 2006; accepted for publication December 1, 2006.


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