Enhancing Adoption of Innovative Clinical Trial Approaches

Event

FDA Convening

Enhancing Adoption of Innovative Clinical Trial Approaches

Day 1 Recording

 

Day 2 Recording

Event Graphics Including Name Time and Date of Event

 

To keep pace with the ever-changing drug development landscape, the U.S. Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) is working extensively to advance innovation in clinical trial design and conduct. CDER’s portfolio of clinical trial innovation includes guidance documents, working groups, public workshops, public-private partnerships, and other programs dedicated to enhancing the design and conduct of clinical trials. While there is increasing momentum to transform clinical trials, many opportunities still exist to improve implementation and adoption of innovations in clinical trial approaches.

The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA, is convening a two-day hybrid public workshop on March 19 & 20 to explore these opportunities and shared strategies for sustainable improvement of clinical studies. The goals of this workshop are to identify key insights to clinical trial modernization efforts around the following topics:

  • Adoption within existing regulatory and compliance guidelines
  • Incorporation of patient experiences for improving participation
  • Evaluation of existing technology, infrastructure, and organizational culture for participation in research
  • Collaborations among regulatory agencies and across industries to facilitate innovation

Ahead of the workshop, the FDA has created a public docket (FDA-2023-N4489) that will inform the planning of the event and CDER’s future work related to clinical trial innovation. Responses can be submitted here and the docket closes on April 19.

 

Funding Acknowledgement:

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [U19FD006602] totaling $5,045,773 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

Duke-Margolis Planning Team

Brian Canter Headshot

Brian Canter, Ph.D.

Policy Research Associate

A headshot of Gerrit, where he stands on a bridge overlooking a forest and wears a light blue collared shirt with a dark blue jacket and light blue pocket square.

Gerrit Hamre, MA

Research Director for Biomedical Regulatory Policy

Dure Kim Headshot

Dure Kim, PharmD

Assistant Research Director