A bayesian approach to the design of phase II clinical trials.
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.
Sylvester
R J
RJ
EORTC Data Center, Brussels, Belgium.
D001499:Bayes Theorem; D003662:Decision Theory; D004341:Drug Evaluation / Q000379:methods*; D006801:Humans; D011336:Probability; D012107:Research Design