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Complex Innovative Trial Design Pilot Meeting 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.

Complex Innovative Trial Designs Brochure (PDF - 438KB)

Advancing the Use of Complex Innovative Trial Designs (CID): Introduction Slides (PDF-889KB)

Complex Innovative Trial Designs (CID) Pilot Meeting Program: Process Slides (PDF-723KB)

Goals of the CID Pilot Meeting Program

The CID Pilot Meeting 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 meeting program, including trial designs for medical products that have not yet been approved by FDA.

Procedures and Submission Information

CID Pilot Meeting Program
Quarterly meeting request submission deadlines
March 31 June 30 Sept. 30 Dec. 31

Applicants will be notified of eligibility to proceed to disclosure discussions approximately 45 days after submission deadlines.

Under the 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.

Frequently Asked Questions

Visit Complex Innovative Trial Design Pilot Meeting Program Frequently Asked Questions for more information about the program.

Contact Us

For submission assistance and inquiries about the CID Pilot Meeting Program, email: [email protected].
This mailbox is monitored daily and replies will be sent within two business days of receipt.

New! CID Pilot Program Trial Design Case Studies

The description of each CID Pilot Meeting Program case study focuses on the single clinical trial design that was the focus of the Pilot Program submission. The description does not discuss other potentially important aspects of the development program for the respective drug or biologic, such as any plans to conduct additional adequate and well-controlled trial(s) and/or to obtain confirmatory evidence to help establish substantial evidence of effectiveness. Please refer to draft guidance Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products (December 2019).

Learn More about CID

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