Today, the FDA launched a pilot meeting program for complex innovative designs (CID) in a Federal Register notice titled, “Complex Innovative Designs Pilot Meeting Program.” (CID) refers to complex adaptive, Bayesian, and other novel designs, with a focus on designs for which simulations are necessary to evaluate the clinical trial properties (e.g. power, type I error probability, etc).
The pilot meeting program offers sponsors who are selected an opportunity to engage with FDA experts from the Center for Drug Evaluation and Research (CDER) and/or the Center for Biologics Evaluation and Research (CBER) to discuss CID approaches and analyses in medical product development.
The pilot program period will run through fiscal year 2022, and is being conducted to fulfill FDA’s performance commitment under PDUFA VI, incorporated as part of the FDA Reauthorization Act of 2017. During the pilot, FDA has committed to accepting up to two meeting requests quarterly, about 120 days apart, to offer feedback on the proposed CID approach within a specific drug development program, and to providing regulatory advice. FDA is exploring the use of CIDs to inform regulatory decision-making and to enhance the understanding and review capacity of CIDs.
For more information about the pilot program and how to apply visit: Complex Innovative Trial Designs Pilot Program
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