Abstract

Tables are presented for the design of randomized play-the winner (RPW) clinical trials to achieve a high probability of selection of the best of two treatments and a balance between the expected number of patients on the inferior treatment and an index of possible patient selection bias. Included is a method of accelerating the divergence of the treatment allocation probabilities as the patient responses accumulate in favor of one treatment over the other. An application of the RPW approach to a clinical trial on the treatment of respiratory distress in newborn infants is discussed. The trial is interpreted in terms of the posterior probability of correct selection given the observed results. A modified design criterion is suggested based upon the selection of a new treatment over a standard control only when the posterior probability of correct seclection is high

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