Deep Historical Borrowing Framework to Prospectively and Simultaneously Synthesize Control Information in Confirmatory Clinical Trials with Multiple Endpoints

08/28/2020

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by   Tianyu Zhan, et al.

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In current clinical trial development, historical information is receiving more attention as providing value beyond sample size calculation. Meta-analytic-predictive (MAP) priors and robust MAP priors have been proposed for prospectively borrowing historical data on a single endpoint. To simultaneously synthesize control information from multiple endpoints in confirmatory clinical trials, we propose to approximate posterior probabilities from a Bayesian hierarchical model and estimate critical values by deep learning to construct pre-specified decision functions before the trial conduct. Simulation studies and a case study demonstrate that our method additionally preserves power, and has a satisfactory performance under prior-data conflict.