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About the Event:

On March 5th, 2024, FDA is conducting a public workshop to discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs.

This meeting is being 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 is 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 will consist of two sessions. The first session will focus on case studies illustrating various aspects of complex innovative designs and implementation. The second session will consist of panel discussions motivated by the case studies. There will be an opportunity for public comment.

FDA is seeking information and comments from a broad range of stakeholders. This website will be updated as meeting materials are developed.

Registration:

Registration will be available starting January 15, 2024.

If you are unable to attend the workshop in person, you can register to view a live webcast of the workshop. You will be asked to indicate in your registration if you plan to attend in person or via the webcast. Onsite seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations.

Contact:

CID.Meetings@fda.hhs.gov