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  6. About CDER Center for Clinical Trial Innovation (C3TI)
  1. CDER Center for Clinical Trial Innovation (C3TI)

About CDER Center for Clinical Trial Innovation (C3TI)

CDER established the CDER Center for Clinical Trial Innovation (C3TI) in April 2024 to enable and amplify innovative approaches to clinical trials that are designed to improve the efficiency and effectiveness of drug development. 

C3TI serves as a central hub to:

  • Facilitate coordination across CDER innovation programs to more easily engage in cross-program and cross-center collaborations. Existing CDER clinical development innovation programs will continue to operate according to their established processes, with C3TI serving to synthesize lessons learned across those programs.
  • Manage a demonstration program that will expand opportunities for sponsors of innovative clinical trials to interact with CDER staff and for these trials to serve as case examples to spur further innovation. More information on the demonstration program can be found on the C3TI Demonstration Program webpage. 
  • Provide CDER staff, drug developers, and other interested parties with a single CDER point of contact to assist with non-product-specific questions related to clinical trial innovation. 
  • Support knowledge sharing through various mechanisms, such as public workshops, discussion forums, communications and a website to centralize information on existing and new CDER clinical trial innovation efforts. More information can be found on the C3TI Knowledge Repository webpage.

Additional Resources

Federal Register Notice – Center for Drug Evaluation and Research Center for Clinical Trial Innovation
CDER Conversation – CDER Launches a Center for Clinical Trial Innovation
CDER Statement – FDA establishes CDER Center for Clinical Trial Innovation (C3TI)

 
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