Insights from
UBC's Expert Voices

Rescue studies are a challenge, and often enrollment is a top reason for switching. But mismatched partnerships go beyond enrollment.

As Real World Evidence (RWE) continues to shape regulatory decision-making, the FDA and Duke Margolis Institute convened a public meeting to share successes, challenges, and lessons learned in RWE submissions. With over 4,000 attendees, the event spotlighted case studies, data feasibility, and the evolving role of RWE in labeling, post-marketing commitments, and registrational trials. Learn how sponsors are partnering with regulators to modernize study design and advance global RWE standards.