Pitfalls And Possibilities: EHRs To RWD Via EDC

Over five years have passed since the FDA granted its first regulatory approval utilizing real-world evidence (RWE). This approval involved a medical device, and the decision was made solely based on data derived from the electronic health records (EHRs) of real-life patients who had utilized the product, rather than relying on data from randomized clinical trials. This milestone was hailed as the dawn of a new era in drug and medical device development and regulation, marked by the systematic utilization of RWE derived from actual usage, also known as real-world data (RWD).

The logical and productive repurposing and analysis of EHR data for clinical research seem apparent, yet the adage that “no opportunity comes without challenges” holds particularly true in this context. Consider DIA GCP & QA Community Chair Terry Katz’s (Daiichi Sankyo, Inc.) perspective on repurposing and evaluating EHR data for clinical research, which has since been transcribed from the DIA Global Annual Meeting 2022 Community Roundtable on Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations.