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  1. CDER Center for Clinical Trial Innovation (C3TI)

C3TI Demonstration Program

CDER Center for Clinical Trial Innovation (C3TI)


The CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program provides the opportunity to test, implement, and scale the integration of innovation into clinical trials through increased communication and interaction between CDER and sponsors of innovative clinical trials in certain project areas.

The program is for selected sponsors of innovative clinical trials in certain initial project areas under a pre-investigational new drug application (pre-IND) or IND with CDER that are intended to support new drug product approvals or changes to approved drug product labeling and that will serve as case examples that can be shared both internally and externally to foster innovation across therapeutic areas. If selected, sponsors will have the opportunity for enhanced communication and interaction with CDER staff.

Sharing Lessons Learned

Because the goal of selecting these case examples from clinical trials under a pre-IND or IND is to ultimately share lessons learned more broadly with the clinical trial community, participating sponsors and FDA will agree on aspects of the development program that FDA can disclose even before a drug is approved. Generally, sponsors participating in demonstration projects will be expected to share select details of their clinical trials and the implementation of clinical trial innovations as they progress. This sharing may include updates, lessons learned, and relevant insights gathered during the course of the trial. It is understood that these shared details will reflect general principles and innovative aspects, while maintaining the necessary confidentiality of proprietary or sensitive information.

Initial Demonstration Project Areas

C3TI selected three initial demonstration project areas, which were prioritized given their alignment with the broader objectives of C3TI, their expected readiness of implementation and scalability, and the opportunity to improve lessons learned. C3TI intends to launch additional demonstration project areas as the C3TI Demonstration Program evolves. 

The initial project areas are: 1) Bayesian Supplementary Analysis; 2) Selective Safety Data Collection; and 3) Streamlined Trials Embedded in clinical Practice.

More information about each of the demonstration project areas, including the eligibility criteria, is available below. The C3TI Demonstration Program will accept up to nine proposals on a rolling basis within a 12-month period. Instructions on how to submit a proposal can be found on the C3TI Demonstration Program Proposal Submission webpage. 

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