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Biometrika 2001 88(1):245-253; doi:10.1093/biomet/88.1.245
© 2001 by Biometrika Trust
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Event-based analysis times for randomised clinical trials

Jack Cuzick1

1 Imperial Cancer Research Fund, 61 Lincoln's Inn Fields, London WC2A 3PX, U.K.e-mail: j.cuzick{at}icrf.icnet.uk

Analysis times for clinical trials are often based on the time when a specified total number of events occur.A modification is proposed in which this time is based on when either arm reaches a prespecified number of events. The implications in terms of the expected number of events required to achieve the same size and power at a specified alternative are explored. Savings are achieved when alternatives for which there is reasonable power hold, but more events are required at the null hypothesis.

Key Words: Analysis time; Inverse sampling; Negative binomial distribution; Negative hypergeometric distribution; Randomised clinical trial; Stopping time


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