FDA Commissioner Scott Gottlieb, MD increasingly emphasizes the need for real-world evidence (RWE) to inform clinical decision-making and innovation. Electronic health record (EHR) will play an increasingly important role in the collection and production of drug intelligence at the FDA. Gottlieb was quoted” Providers and other stakeholders are exploring effective ways to leverage electronic tools to gather vast amounts of health-related data from EHRs and other sources.” Moreover, Gottlieb concluded “and they’re working on ways to use advanced analytics, including machine-learning algorithms, to transform data into evidence that can be used to help guide clinical decision-making or inform innovators during the development of medical products.”
The FDA will increasingly support real-world data collection in the context of clinical trials. The FDA under Gottlieb titling the concept as “Decentralized clinical trials”—where data will increasingly come from the real-world—including randomization—outside of traditional clinical research site boundaries and including EHRs as well as a growing array of digital health tools such as wearables.