"Increasingly, vast amounts of health-related data are being generated by a diverse array of sources, such as EHRs, medical claims, product and disease registries, laboratory test results and even consumer mobile devices. Because such data reflect 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. The FDA refers to this as the generation of Real-World Evidence, or RWE.
Please join federal officials for an overview of the FDA’s Framework for Real-World Evidence Program, and learn about what RWE efforts are currently underway at agency’s Center for Drug Evaluation and Research. This is the second in a series of Webinars hosted by AMIA’s Public Policy Committee, where the informatics community is introduced to federal programs and agency officials working at the cutting edge of health informatics policy."