Journal
STATISTICS IN MEDICINE
Volume 22, Issue 5, Pages 677-687Publisher
JOHN WILEY & SONS LTD
DOI: 10.1002/sim.1429
Keywords
clinical trials; futility; interim analyses; sequential methods; stochastic curtailment
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This paper introduces a simple futility design that allows a comparative clinical trial to be stopped due to lack of effect at any of a series of planned interim analyses. Stopping due to apparent benefit is not permitted. The design is for use when any positive claim should be based on the maximum sample size, for example to allow subgroup analyses or the evaluation of safety or secondary efficacy responses. A final frequentist analysis can be performed that is valid for the type of design employed. Here the design is described and its properties are presented. Its advantages and disadvantages relative to the use of stochastic curtailment are discussed. Copyright (C) 2003 John Wiley Sons, Ltd.
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