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?
![EvGen Report](/sites/default/files/inline-images/MicrosoftTeams-image%20%281%29_0.png)
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