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Stopping clinical trials because of treatment ineffectiveness: a comparison of a futility design with a method of stochastic curtailment
Author(s) -
Whitehead John,
Matsushita Tatsuru
Publication year - 2003
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.1429
Subject(s) - frequentist inference , interim , interim analysis , early stopping , sample size determination , computer science , clinical trial , statistics , econometrics , medicine , mathematics , bayesian probability , machine learning , bayesian inference , pathology , artificial neural network , archaeology , history
Abstract 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 © 2003 John Wiley & Sons, Ltd.