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Workshop | Mixed

Event Title
Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice
March 5, 2024

March 5, 2024
9:00 AM - 3:30 PM ET
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 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.

This website will be updated as meeting materials are developed. For more information about complex innovative trial design, please visit FDA’s website, Complex Innovative Trial Design Meeting Program.


To register for this meeting, visit: https://ComplexInnovativeDesignsWorkshop.eventbrite.com

Registration for in-person attendance will be open until February 27, 2024.

Registration for online attendance via webcast will remain open through the day 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.

Meeting Materials:

Agenda: Advancing the Use of Complex Innovative Designs in Clinical Trials 
Panelist Biographies

Public Docket:

Stakeholders are invited to submit comments through the public docket. The public docket will close on April 5, 2024.




Event Materials

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