All Times EDT
Keywords: Bayesian; clinical trials; master protocol
Beneficial therapeutic strategies are established through a gradual process devised to define the safety and efficacy profiles of new strategies over a sequence of clinical trials. This system produces redundancies, whereby similar treatment strategies are replicated, either as experimental or comparator standard-of-care therapies, across development phases and multiple studies. This article describes a collection of web-based statistical tools hosted by MD Anderson Cancer Center that enable investigators to incorporate historical control data into analysis of randomized clinical trials using Bayesian hierarchical modeling as well as implement adaptive designs using the method described in Hobbs et al. (2013). By balancing posterior effective sample sizes among the study arms, the adaptive design attempts to maximize power on the basis of interim posterior estimates of bias. With balanced allocation guided by hierarchical modeling, the design offers the potential to assign more patients to experimental therapies and thereby enhance efficiency while limiting bias and controlling average type I error.