Enhancing Adoption of Innovative Clinical Trial Approaches
Contact InformationLuke Durocher
The FDA Center for Drug Evaluation and Research (CDER) helps advance drug development by providing scientific and regulatory direction. CDER works in a rapidly evolving ecosystem, where the focus is moving towards rare diseases and common disease subset populations to be addressed by novel drug developments. These shifts in the drug development landscape require innovative approaches and novel clinical trial designs to expand drug development tools and improve the use of real-world evidence.
To keep pace with this everchanging drug development landscape, 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, there are still many barriers to implementation and adoption of innovations in clinical trial approaches.
The Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, is convening a two-day hybrid Public Workshop on March 19-20, to identify these barriers and potential strategies across all stakeholders. The goals of this workshop are to identify key challenges in clinical trial modernization efforts around the following topics:
- Regulatory and Compliance Considerations
- Patient-Centricity and Recruitment Innovations
- Clinical Trial Infrastructure and Organizational Culture
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 more information on the workshop will be available in January 2024.