The State of Real-World Evidence Policy 2025

Convened with the Duke-Margolis Real-World Evidence Collaborative, this public meeting will provide a venue to review recent RWE Collaborative activities, strategic real-world data and real-world evidence (RWD/E) policy developments, and promising future applications of RWD/E.

The opening fireside chat will feature two former U.S. Food and Drug Administration Commissioners: Duke-Margolis Director Mark McClellan and Rob Califf. They will share their thoughts on how U.S. regulators, policymakers, and payers should approach RWE generation given the new policy and health care landscape.

This year, panelists will discuss a few other timely topics:

• Opportunities to harmonize, collaborate, and make progress globally in the RWD/E community
• How to cultivate research into routine care and advance pre- and post-market evidence generation
• Uses of RWD/E to support pricing, coverage, and payment
• Ways that RWE can support regulatory decision-making, using recent use cases to illustrate lessons learned