Bayesian Method of Borrowing Study-Level Historical Longitudinal Control Data for Mixed-Effects Models with Repeated Measures.

Abstract

Bringing historical control information into a new trial appropriately holds the promise of more efficient trial design with more accurate estimates, increased power, and fewer patients allocated to inefficacious control group, provided the historical control data are sufficiently similar to the concurrent control. Interest has been growing over the past few decades in leveraging historical clinical trial on the control arm. However, most of the current historical borrowing methods focus on incorporating patient-level historical control information at only one time point. In this work, we propose a Bayesian hierarchical Mixed effect Models for Repeated Measures to incorporate aggregated study-level longitudinal historical control estimates into the concurrent trial that collected repeated longitudinal data. The simulation study demonstrates that, as compared to one time point data analysis approach, leveraging longitudinal historical control data produces greater power enhancement and mitigates the power loss when the missing data under missing at random mechanism is present. Our work also helps fill the gap of lack of methods borrowing historical longitudinal control data from the published summarized estimates when patient-level control data are not available.