CDER Seeks Innovative Clinical Trial Designs for Demo Project

A new CDER sub-center is looking for drug developers with specific in-process studies for a demonstration program intended to boost innovation in clinical trial design.

The Center for Clinical Trial Innovation (C3TI), activated on April 15, will choose up to nine sponsors with innovative clinical trials currently under a pre-Investigative New Drug or IND designation with CDER. The trials must be intended to support new drug product approvals or changes to approved drug product labeling. The goal is to use these projects as case examples that can be shared both within and outside the FDA to help foster innovation across all therapeutic areas.

Applicants for the C3TI Demonstration Program should be conducting either point-of-care or pragmatic trials, Bayesian analyses, or trials using selective safety data collection. Sponsors chosen to participate will be expected to share details of their clinical trials and the implementation of clinical trial innovations as they progress, CDER said.

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