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Pilot Program for encouraging the complex trial designs for Drugs and Biologics launched by USFDA

USFDA has launched a pilot program to support the use of complex innovative trial designs in the development of drugs and biologics. The launch of pilot program was decided after discussion held during a public meeting held in March although certain concerns were raised by stakeholders such as Genetech and Biogen regarding flexibility and scope of such trials.

FDA will select sponsors based on the criteria for participation in the “Complex Innovative Designs Pilot Meeting Program” which involves an initial and follow up meeting on a design and product within about 120 days .Selected sponsors will receive a summary within 60 days of each meeting. Such sponsors will be able to engage staff in early discussions on approaches to complex designs. Sponsors have time until 30 June 2022 to submit meeting requests as the pilot program will be operational by 30 September 2022. Upto two meeting requests on a quarterly basis each year will be accepted throughout the pilot program duration. There is a process of submitting the meeting request and recommended formatting of the information package which selected sponsors have to follow while submitting it electronically to USFDA.

Trials have been designed as a part of the pilot fulfill commitment under the sixth iteration of the Prescription Drug User Fee Act. FDA will use these complex trials to develop case studies. This program will lead to acceleration of the development of products in areas of unmet need and encouragement in knowledge exchange thereby paving path for advancement of scientific community’s approach in designing clinical trials overall.