FDA Publishes Complex Innovative Trial Design Program Case Studies - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Publishes Complex Innovative Trial Design Program Case Studies  Today, the FDA published a series of case study examples to educate stakeholders and to promote innovation in the area of Complex Innovative Trial Designs (CID). The CID Pilot Meeting Program, launched in 2018, is designed to advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. The program offers sponsors an opportunity for increased interaction with the FDA to discuss specific considerations for a proposed CID. Disclosure agreements between FDA and participating sponsors allow FDA to publicly present case studies of CIDs from the meeting program, including CIDs used to study drugs that have not yet been approved. The published case studies include discussions of the innovative design characteristics, potential design benefits, proposed design considerations, and simulations performed to determine the CID's statistical properties. FDA is publicly sharing these examples to help sponsors understand important factors that should be considered when proposing the use of a CID. For more information on the CID Pilot Meeting Program and to view case study examples, please visit Complex Innovative Trial Design Pilot Meeting Program.   To learn more about the CID Pilot Meeting Program's progress, visit "The U.S. Food and Drug Administration's Complex Innovative Trial Design Pilot Meeting Program:  Progress to date," published in Clinical Trials in December 2021. The article includes background information about CIDs, the CID Pilot Meeting Program, and an overview of the five CID meeting requests granted to date.  Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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