Duke-Margolis has launched a Real-World Evidence Collaborative to advance policy development related to the regulatory acceptability of real-world evidence (RWE). The Collaborative will engage major stakeholders to help advise and guide high priority efforts aimed at improving the development and use of RWE, with the express aim of informing and supporting the FDA as it works to meet RWE milestones as established in the 21st Century Cures Act and the sixth Prescription Drug User Fee Act (PDUFA VI).
The RWE Collaborative will consist of an advisory group that will include senior representation from medical product developers, payers, research groups, providers, patient networks, and regulators. This group will steer Collaborative working groups and contribute to the Collaborative’s recommendations.
Initial projects in the Collaborative’s first year will explore primary considerations for assessing the quality of real-world data (RWD) sources, promising opportunities to improve the credibility of observational study designs, and lessons learned from actual industry experience with RWD- and RWE-enabled regulatory submissions.
Duke-Margolis Project Team
Mark B. McClellan, MD, PhD
Director and Robert J. Margolis, M.D., Professor of Business, Medicine and Policy
Gregory W. Daniel, PhD, MPH, RPh
Deputy Director, Policy and Clinical Professor, Fuqua School of Business
Adrian Hernandez, MD, MHS
Vice Dean for Clinical Research, School of Medicine
Professor of Medicine, Cardiology
Associate Director, Duke Clinical Research Institute
Morgan Romine, MPA
This project is made possible through the generosity of the Margolis Family Foundation, which provides core resources for the Center, as well as a combination of financial and in-kind contributions from consortium members including AbbVie; Eli Lilly and Company; Genentech, a member of the Roche Group; GlaxoSmithKline; Johnson & Johnson; Merck; Novartis; Teva and UCB.
Participation of private or non-profit organizations in Center activities does not imply an endorsement by Duke University or associated entities. As part of Duke University, Duke-Margolis honors the tradition of academic independence on the part of its faculty and scholars. Neither Duke nor the Margolis Center take partisan positions, but the individual members are free to speak their minds and express their opinions regarding important issues. Duke Margolis adheres to all institutional policies on research independence and conflict of interest.