A Post-Marketing Drug Evaluation Framework Based on Real-World Electronic Health Records Data.

Abstract

Real-world data (RWD) could be a new way to evaluate the safety and efficacy of post-marketing drugs, while there is no common method for how to use RWD for drug evaluation. In this paper, we present a framework for real-world drug evaluation based on electronic medical record (EHR) data. We designed a data model customized for post-marketing drug evaluation and a unified post-marketing drug evaluation pipeline. The proposed framework can be applied to drug evaluations with different study paradigms for different purposes by flexible use of the proposed data model and pipeline. A prototype system has been developed according to the framework. Real-world EHRs in a tertiary hospital in China between 2010 and 2020 were converted to the proposed data model, and as a test case, we conducted a research on the risk of allergic reactions to cefodizime and ceftriaxone using the prototype system.