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Regulatory Focus™ > News Articles > 2 > FDA to Hold Meeting on Complex Trial Designs to Inform Guidance, Pilot

FDA to Hold Meeting on Complex Trial Designs to Inform Guidance, Pilot

Posted 23 February 2018 | By Zachary Brennan 

FDA to Hold Meeting on Complex Trial Designs to Inform Guidance, Pilot

The US Food and Drug Administration will hold a meeting on 20 March to discuss the use of complex innovative designs (CID) in clinical trials of drugs and biological products to inform regulatory decision making.

The meeting is intended to help the agency develop a guidance document on the subject, as required by the 21st Century Cures Act, which directs FDA to develop guidance to address several areas related to CID, including “the use of complex innovative clinical trial designs, ways sponsors may obtain feedback on technical issues related to simulations, the submission of resulting information, the types of quantitative information that should be submitted for review, and recommended analysis methodologies.”

The meeting will consist of four sessions on complex adaptive designs; other designs such as use of external/historical control subjects, Bayesian designs and master protocols; clinical trial simulations for confirmatory trial design and planning; and the CID pilot program. Following each session there will be an opportunity for public comment.

FDA said previously the pilot program will be for "highly innovative trial designs for which analytically derived properties (e.g., Type I error) may not be feasible, and simulations are necessary to determine trial operating characteristics."

In addition to meeting the Cures requirement, this meeting will help the agency meet the performance goal of convening a public workshop on such trial designs, as included in the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). Another provision of PDUFA VI requires FDA by the end of FY 2020 to publish a draft guidance describing approaches to facilitate the collection of meaningful patient input in clinical trials. 

Federal Register

Promoting the Use of Complex Innovative Designs in Clinical Trials


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