Demonstration Program

The CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program provides an opportunity to test and scale the integration of innovative approaches in clinical trials. The program offers a mechanism for early engagement between CDER and sponsors of clinical trials implementing select innovative approaches. The program is open to selected sponsors conducting innovative clinical trials under a pre-investigational new drug application (pre-IND) or IND with CDER. These trials should be intended to support new drug approvals or changes to approved drug labeling.

Demonstration Project Areas

C3TI prioritized three initial demonstration project areas based on their alignment with C3TI’s broader objectives, readiness for implementation and scalability, and potential to generate meaningful insights. Additional project areas may be added as the program evolves.

The current project areas are:

More information about each demonstration project area, including eligibility criteria, can be found on their respective webpages (see links above).

Procedures and Submission Information

Instructions on how to submit a proposal can be found on the C3TI Demonstration Program Proposal Submission webpage.

If selected, sponsors will benefit from enhanced communication with CDER staff, including C3TI coordination support for formal meetings to receive timely, focused feedback on the innovative elements of the trial.

The nature and frequency of communication will vary based on the demonstration project area(s) and the specific innovations being applied. Typically, this will include a formal initial meeting to discuss the proposed trial and key design considerations, followed by a tailored engagement approach to support critical milestones such as protocol development and study start-up.

CDER staff, including review team members and relevant subject matter experts, will participate in these discussions and provide timely feedback.

Sharing Lessons Learned

A key objective of the C3TI Demonstration Program is to share insights related to the innovative elements of selected trials with the broader clinical trial community. To support this goal, participating sponsors and FDA will agree on what aspects of the development program can be shared publicly.

Generally, participating sponsors will be expected to share select details of their clinical trials and the implementation of innovative approaches as the trials progress. This may include updates and insights that focus on general principles and innovative aspects while maintaining the necessary confidentiality of proprietary or sensitive information.