Integrating Clinical Studies Into Health Care Delivery: Post-Market Evidence Generation for Medical Products

Integrating Clinical Studies Into Health Care Delivery:
Post-Market Evidence Generation for Medical Products
Virtual Public Meeting
November 14, 2023 | 3:30-5pm (Eastern)

How can FDA and other stakeholders better facilitate and support post-market pragmatic evidence generation studies – studies that answer clinically meaningful questions and address gaps in clinical evidence that directly impact how care is managed in the United States?

On November 14 we released the Enhancing Post-Market Evidence Generation for Medical Products report that details 30 recommendations for creating successful, resource-efficient pragmatic studies in health care delivery settings.

Our expert panel overviewed the report recommendations and shared insights on facilitating a more effective evidence generation strategy that

• simplifies protocol objectives and endpoints to focus on clinically meaningful outcomes
• broadens patient involvement and eligibility
• streamlines adverse event reporting and required data collection
• reduces administrative burden
• creates structured clinical data elements and electronic data capture