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The agency is looking to leverage real-world health data to support drug development.
FDA announced on Dec. 6, 2018 a new strategic framework for advancing drug development based on real-world data (RWD). The healthcare industry has been developing new electronic tools to gather health-related data that FDA says can be used to improve regulatory decisions regarding the development of drugs and biologics as well as postmarket drug safety monitoring.
The Framework for the Real-World Evidence Program will apply across FDA drug and biologic review programs to leverage this information to help the agency make important decisions. The program will include demonstration projects, stakeholder engagement, internal processes to promote shared learning, and guidance documents to assist drug developers in using RWD to develop real-word evidence.
“RWD collected from a variety of sources offer new opportunities to generate evidence and better understand clinical outcomes. These data may be derived from a diverse array of sources, such as electronic health records (EHR), medical claims, product and disease registries, laboratory test results, and even cutting-edge technology paired with consumer mobile devices. These data are being used to develop information and real-world evidence (RWE) that can better inform regulatory decisions. Because they include data covering the experience of physicians and patients with the actual use of new treatments in practice, and not just in research studies, the collective evaluation of these data sources has the potential to inform clinical decision making by patients and providers, develop new hypotheses for further testing of new products to drive continued innovation and inform us about the performance of medical products,” said FDA Commission Scott Gottlieb, MD, in a statement.