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A Bayesian Approach to the Design of Phase II Clinical Trials

Richard J. Sylvester
Biometrics
Vol. 44, No. 3 (Sep., 1988), pp. 823-836
DOI: 10.2307/2531594
Stable URL: http://www.jstor.org/stable/2531594
Page Count: 14
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A Bayesian Approach to the Design of Phase II Clinical Trials
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Abstract

A new strategy for the design of Phase II clinical trials is presented which utilizes the information provided by the prior distribution of the response rate, the costs of treating a patient, and the losses or gains resulting from the decisions taken at the completion of the study. A risk function is derived from which one may determine the optimal Bayes sampling plan. The decision theoretic/Bayesian approach is shown to provide a formal justification for the sample sizes often used in practice and shows the conditions under which such sample sizes are clearly inappropriate.

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