Keywords: hybrid controls, RCT, clinical trials,
High quality curated electronic health record (EHR) data collected during routine clinical care of patients have the potential to supplement and complement data from clinical trials and accelerate drug development. In areas of high unmet need, randomized controlled trials (RCT) with hybrid controls (where the data in the comparator arm is derived from randomized controls and external sources) provide a novel way to evaluate the effectiveness of experimental regimens while limiting randomization of patients to potentially ineffective treatment regimens. Furthermore, by leveraging external data, RCTs with hybrid controls have the potential to gain efficiencies in cost and timelines, and accelerate patient access to more effective therapies. We explored the use of EHR data for the development of hybrid control arms in RCTs. In this presentation, we will review statistical methodologies published in this space (including Bayesian commensurate prior models), showcase results of our simulation studies comparing the methodologies, and discuss important considerations specific to the use of EHR data in such designs.