Promoting the Use of Complex Innovative Designs in Clinical Trials; Public Meeting; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Promoting the Use of Complex Innovative Designs in Clinical Trials.'' The topic to be discussed is 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. FDA is seeking comments on the use of CID to inform regulatory decision making and is also seeking input on the CID pilot program.