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.
Complex Innovative Trial Designs Pilot Program
As displayed in the Federal Register notice on August 29, 2018, FDA is conducting a Complex Innovative Trial Design (CID) Pilot Meeting Program to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The CID Pilot Meeting Program fulfills a performance goal agreed to under PDUFA VI, included as part of the FDA Reauthorization Act of 2017.
This pilot 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 2019 to 2022. To promote innovation in this area, trial designs developed through the pilot 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 FDA.
Goals of the CID Pilot Meeting Program
The CID Pilot Program is designed to:
- Facilitate the use of CID approaches in late-stage drug development.
- Promote innovation by allowing FDA to publicly discuss the trial designs considered through the pilot program, including trial designs for medical products that have not yet been approved by FDA.
Procedures and Submission Information
Under the CID pilot meeting program, FDA will accept two primary meeting requests and two alternates per quarter. For each meeting request granted as part of the pilot, FDA will conduct an initial meeting and a follow-up meeting on the same CID and medical product within a span of approximately 120 days.
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