FDA, Duke RWE Meeting To Address Study Designs, Challenges, Safety

FDA and the Duke Margolis Center for Health Policy will host a meeting July 11 to discuss using randomized clinical trial designs and real-world data to generate real-world evidence, the agency announced Friday (June 7). The meeting will delve into study designs, potential challenges and how to capture outcomes, as well as regulatory issues surrounding safety, product monitoring and data integrity. The meeting, “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes,” is another step in the agency’s...