Promoting the Use of Complex Innovative Designs in Clinical Trials

On March 20th, FDA is conducting a public workshop to discuss the use of complex innovative designs (CID) in clinical trials of drugs and biological products to inform regulatory decision making.

This meeting will inform development of a guidance document as required by the 21st Century Cures Act (Cures Act) and is being conducted to meet the performance goal of convening a public workshop on CID included in the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA). This meeting will also inform the development of a CID pilot program.

The purpose of this public meeting is to:

(1) facilitate discussion and information sharing about the use of CID in drug development and regulatory decision making

(2) obtain input from stakeholders about the CID pilot program.

FDA is seeking information and comments from a broad range of stakeholders.

Please visit the FDA website for the meeting for additional information and meeting materials.