CDER Center for Clinical Trial Innovation (C3TI)
The Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI) is a hub to improve the efficiency of drug development through innovative clinical trial approaches.
C3TI promotes innovation by:
- Advancing knowledge sharing through public workshops, forums, outreach, and the C3TI knowledge repository.
- Facilitating collaboration across CDER’s innovation programs.
- Managing a Demonstration Program to test and scale innovative approaches to clinical trials and expand opportunities for engagement between drug developers and CDER staff.
- Serving as a central point of contact for non-product-specific questions related to clinical trial innovation.
C3TI is governed by leadership from the Office of the Center Director, Office of Compliance, Office of Medical Policy, Office of New Drugs and Office of Translational Sciences.
Connect with us
Email: CDERclinicaltrialinnovation@fda.hhs.gov
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Featured C3TI Demonstrations & Activities
Demonstration Program
Offers a mechanism for early engagement between CDER and sponsors implementing select innovative approaches in clinical trials
Bayesian Statistical Analysis
C3TI aims to increase the use and understanding of Bayesian statistical methods in simple clinical trial settings
Selective Safety Data Collection (SSDC) Demonstration Project
C3TI aims to promote the adoption of SSDC principles into appropriate drug development programs
Streamlined Trials Embedded in clinical Practice (STEP) Demonstration Project
C3TI looks to engage with sponsors planning trials with pragmatic elements that reflect routine clinical practice