Bayesian Study Design
A Bayesian Study Design For Seamless Transition Between Phase II And Phase III
Data collected by a sponsor suggested a possibility of a differential treatment in subpopulations defined by levels of a biomarker. A Bayesian study design has been developed, which allows the sponsor to conduct a randomized Phase II trial to corroborate the finding and to seamlessly continue to Phase III in the subpopulation, which benefits from the treatment. The study design was consulted and accepted by a regulatory agency.