Bayesian hierarchical classification and information sharing for clinical trials with subgroups and binary outcomes.

Bayesian hierarchical models have been applied in clinical trials to allow for information sharing across subgroups. Traditional Bayesian hierarchical models do not have subgroup classifications; thus, information is shared across all subgroups. When the difference between subgroups is large, it suggests that the subgroups belong to different clusters. In that case, placing all subgroups in one pool and borrowing information across all subgroups can result in substantial bias for the subgroups with strong borrowing, or a lack of efficiency gain with weak borrowing. To resolve this difficulty, we propose a hierarchical Bayesian classification and information sharing (BaCIS) model for the design of multigroup phase II clinical trials with binary outcomes. We introduce subgroup classification into the hierarchical model. Subgroups are classified into two clusters on the basis of their outcomes mimicking the hypothesis testing framework. Subsequently, information sharing takes place within subgroups in the same cluster, rather than across all subgroups. This method can be applied to the design and analysis of multigroup clinical trials with binary outcomes. Compared to the traditional hierarchical models, better operating characteristics are obtained with the BaCIS model under various scenarios.