Tuesday, April 7, 2020

Tuesday, April 7, 2020

Lilly accepted to FDA’s Complex Innovative Trial Designs Pilot Meeting Program

Eli Lilly and Co. was recently accepted into the U.S. Food and Drug Administration’s (FDA) Complex Innovative Trial Designs (CID) Pilot Meeting Program. 

The CID program is an FDA initiative under the 21st Century Cures Act to further modernize drug development, improve efficiency and promote innovation. Lilly wants to specifically focus on the unmet needs of those in the United States who suffer with chronic pain.

"Chronic pain poses unique scientific, medical and social problems, and Lilly is dedicated to collaborating with regulatory agencies, physicians and patient advocacy groups across the health care ecosystem in order to help address these problems," Mark Mintun, M.D., vice president of pain and neurodegeneration research at Lilly, said in a press release. "Real solutions will depend on a holistic transformation in the way we investigate these new medicines in clinical trials, and we are excited about our participation in the CID program as one way to accelerate this research to enable better treatment options for patients."

The CID program looks for participants based on the goal of facilitating and advancing the use of complex adaptive, Bayesian and new clinical trial designs.

"Lilly is excited to partner with the FDA on this innovative trial, which will evaluate multiple interventions in several chronic pain conditions via one streamlined clinical protocol," Karen Price, Ph.D., senior research advisor, Statistical Innovation Center at Lilly, said in the release. "This design will enable both statistical advances and operational efficiencies, facilitating faster evaluation of potential solutions. The learning from this CID will contribute to broader utilization of the innovative statistical approaches required for these types of designs."

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