Adaptive Bayesian Designs for Dose-Ranging Drug Trials

In the standard type of phase II efficacy trial, patients are assigned to a dose from among those being considered (usually 4 to 12 in number). Assignment is random, usually with equal numbers of patients assigned to each dose. Based on the results of the trial, a decision is made to either enter phase III in the drug’s development, stop the drug’s development, or conduct another phase II trial. Such a design is inefficient, in terms of both time and resources. We have developed an innovative class of designs that we are introducing into practice. In this case study we describe the designs, address difficulties in implementing them in actual clinical trials, and relay our experience with using them.

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