- Date:
- March 5, 2024
- Time:
- 9:00 AM - 3:30 PM ET
- Location:
-
Event Location
White Oak Campus: The Great Room
Conference Center
10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States
About the Event
On March 5, 2024, FDA conducted a public workshop to discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs.
This meeting was conducted to meet the performance goal of convening a public workshop on complex innovative design (CID) included in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII).
The purpose of this public workshop was to facilitate discussion on the use of external data sources, Bayesian statistical methods, and simulations in complex innovative trial designs as well as trial implementation.
The meeting consisted of two sessions. The first session focused on case studies illustrating various aspects of complex innovative designs and implementation. The second session consisted of panel discussions motivated by the case studies.
For more information about complex innovative trial design, please visit FDA’s website, Complex Innovative Trial Design Meeting Program.
Meeting Materials
Public Docket
Stakeholders were invited to submit comments through the public docket. The public docket closed on April 5, 2024.
