FDA, Guidelines

FDA launches pilot program in support of complex trial designs for drugs and biologics

The FDA announced a new pilot program Wednesday aimed at encouraging the use of complex innovative trial designs in the development of drugs and biologics.

Sponsors selected by the FDA based on the criteria for participation in the “Complex Innovative Designs Pilot Meeting Program” will be able to engage staff in early discussions on approaches to complex designs.

Scott Gottlieb

The pilot will remain operational through 30 September 2022, but sponsors have until 30 June 2022 to submit meeting requests, according to Wednesday’s notice. Meetings under the pilot will be conducted by FDA’s Center for Drug Evaluation and Research or its Center for Biologics Evaluation and Research.

Trials designed as part of the pilot, which fulfills a commitment under the sixth iteration of the Prescription Drug User Fee Act, will be used by the FDA to develop case studies. Up to two meeting requests will be accepted on a quarterly basis each year throughout the pilot’s duration.

Participation involves an initial and a follow-up meeting on a design and product within about 120 days, and the selected sponsors will receive a summary “within 60 days of each meeting,” the notice adds.

The notice also explains the process for submitting meeting requests and the recommended formatting of the information package selected sponsors are required to submit electronically to the FDA.

Plans to launch the pilot were first discussed during a public meeting in March, though certain concerns were raised by stakeholders such as Genentech and Biogen regarding flexibility and scope.

“Through interaction between FDA and pilot participants, this program will help accelerate the development of products in areas of unmet need, and ensure knowledge exchange to help advance the scientific community’s approach to designing clinical trials overall…,” FDA Commissioner Scott Gottlieb said in a Wednesday post. He also pointed to other recent efforts aimed at achieving the pilot’s goals.

The related efforts include new draft guidance documents on seamless clinical trials for expedited drug development and on the use of placebo-controlled trial designs, both of which were issued this month.


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information. 


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