The FDA is continuing the Complex Innovative Trial Design (CID) Paired Meeting Program, originally established under PDUFA VI, to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The CID Paired Meeting Program fulfills a performance goal agreed to by the Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs) 2023-2027, known as PDUFA VII.
This paired meeting program offers sponsors whose meeting requests are granted the opportunity for increased interaction with FDA staff to discuss their proposed CID approach. Meetings will be conducted by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) during fiscal years 2023 to 2027. To promote innovation in this area, trial designs developed through the meeting program may be presented by FDA (e.g., in a guidance or public workshop) as case studies, including trial designs for medical products that have not yet been approved by the FDA.1
The CID Paired Meeting Program is designed to:
- Facilitate the use of CID approaches with emphasis in late-stage drug development.
- Promote innovation by allowing FDA to publicly discuss the trial designs accepted by the paired meeting program, including trial designs for medical products that have not yet been approved by FDA.
You can read more and apply for a meeting by clicking this link.
References
- Research, C. F. D. E. A. (2023). Complex Innovative Trial Design Meeting Program. U.S. Food And Drug Administration. https://www.fda.gov/drugs/development-resources/complex-innovative-trial-design-meeting-program
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- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
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