CDER Center for Clinical Trial Innovation (C3TI)

The Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI) is a central hub that supports innovative approaches to clinical trials that are designed to improve the efficiency of drug development. C3TI aims to promote existing CDER programs and spur future clinical trial innovation activities through enhanced communication and collaboration. 

C3TI will enable internal and external parties to access information on clinical trial innovation efforts more easily, engage in collaborations, identify resources that can further support the use of innovative modalities, and find development programs where a concerted approach to the use of clinical trial innovations would be impactful. The goals of these efforts are to help those involved in clinical research in staying current with clinical trial innovations, improve the efficiency and effectiveness of clinical trials, help increase the participation of diverse populations in clinical trials, and, in turn, accelerate the development of safe and effective new drugs.

C3TI is governed by leadership from the following CDER offices:

• Office of the Center Director
• Office of Communications
• Office of Compliance
• Office of Medical Policy
• Office of New Drugs
• Office of Translational Sciences

Connect with us

CDERclinicaltrialinnovation@fda.hhs.gov

Video by CDER Center Director and Office of New Drugs leadership

Watch Dr. Patrizia Cavazzoni and Dr. Kevin Bugin share more about the vision and mission of C3TI

Demonstration Program

Learn about C3TI demonstration projects and how they provide the opportunity to test, implement, and scale the integration of innovation into clinical trials

About C3TI

Discover the core activities of C3TI established to enable and amplify innovative approaches to clinical trials

Frequently Asked Questions

See how C3TI impacts drug development, regulatory review, and sponsors’ interactions with CDER staff

Clinical Trials Day

Learn about Clinical Trials Day, which is an opportunity to celebrate all the individuals involved in clinical research.