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September 6, 2019updated 23 Dec 2019 9:32am

FDA accepts Lilly’s protocol of pain trial for CID initiative

The US Food and Drug Administration (FDA) has accepted Eli Lilly’s pain clinical trial for the Complex Innovative Trial Designs (CID) Pilot Meeting Program.

The US Food and Drug Administration (FDA) has accepted Eli Lilly’s pain clinical trial for the Complex Innovative Trial Designs (CID) Pilot Meeting Program.

CID is being conducted by the regulator to allow and advance the use of complex adaptive, Bayesian, and other new trial designs. The initiative is intended to modernise drug development and enhance efficiency.

Lilly proposed a single master protocol for the development of multiple new methods to treat different forms of chronic pain. The company expects its design to facilitate quicker clinical assessment.

Eli Lilly Statistical Innovation Center senior research advisor Karen Price said: “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.

“Real solutions will depend on a holistic transformation in the way we investigate these new medicines in clinical trials.”

“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 utilisation of the innovative statistical approaches required for these types of designs.”

Pain is considered chronic when it persists for three months and above. Chronic pain impacts daily living, general activity, as well as social and family interactions, and can lead to severe work restrictions.

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Affecting nearly 20% of the population, chronic pain is said to be the reason behind 15% to 20% of all physician visits. The condition is estimated to be associated with a $560bn to $635bn cost burden.

Lilly pain and neurodegeneration research vice-president Mark Mintun said: “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 programme as one way to accelerate this research to enable better treatment options for patients.”

The company’s pain portfolio includes Galcanezumab for cluster headache, Lasmiditan to treat migraine, as well as Tanezumab for cancer pain, chronic lower back pain, and osteoarthritic pain.

Galcanezumab secured FDA approval, while Lasmiditan is under regulatory review and Tanezumab in Phase III development. Lilly also has multiple products in Phase I.

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