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In some clinical development programs, there are potential biomarkers with promising but uncertain predictive effect, while the probability of success in the overall population cannot be readily dismissed. It is risky to focus only on the overall population, or just the biomarker subpopulation. In 2009, Chen and Beckman proposed a Bayesian decision framework to optimize the type I error rate (alpha)...
A key component of modern drug development is to identify the patient population(s) that benefit most from the therapy. Subjects with different biomarker/genetic profiles may respond to a therapy differently. At the same time, data of populations with best efficacy may not be available due to lack of randomized data or biomarker assay when designing the phase III confirmatory trials. In this manuscript,...
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