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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 that will illustrate various aspects of complex innovative designs and implementation. The second session will consist of panel discussions motivated by the case studies. Interested parties are encouraged to register early. Registration is required for in-person attendance and will be open until February 27, 2024. Registration for online attendance via webcast will remain open through the day of the workshop. Hybrid Experience: The workshop offers both in-person and virtual attendance options. In-Person Attendance: The in-person event will be held at FDA White Oak Campus in the Great Room in Silver Spring, MD. Entrance for the public meeting participants (non-FDA employees) is through Building 1. Please allow time for routine security checks, as screening procedures will be performed. For parking and security information, please refer to the following link: FDA Visitor Information Virtual Attendance: For those attending virtually, information on accessing the online webcast can be found in the registration confirmation email. On the day of the meeting, if you have trouble connecting to the webcast, please email: virtual-wocc-support@fda.hhs.gov For any other questions, please email CID.Meetings@fda.hhs.gov. Special Accommodations: If you need special accommodations due to a disability, please contact Tuan Pham at CID.Meetings@fda.hhs.gov no later than February 20, 2024. Closed captioning will be available to virtual attendees.

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