FDA official offers updates on C3TI, knowledge repository

The US Food and Drug Administration’s (FDA) recently launched CDER Center for Clinical Trial Innovation (C3TI) is meant to inform sponsors about innovative approaches to clinical trials, said Kevin Bugin, deputy director of operations in the Office of New Drugs (OND) and the leader of the C3TI program.

Bugin discussed the program, which launched in April, and other recent developments during the agency’s Regulatory Education for Industry (REdI) meeting on 29 May. He said the agency wants to work with sponsors to tailor and leverage innovative trial approaches for their research. (RELATED: FDA launches new clinical trial center to improve innovation, communication, Regulatory Focus 15 April 2024)

Burgin said the goal of C3TI is to “amplify” and broadly share information about innovative trials. “One trial in the context of oncology may not be super relevant to someone doing a trial in dermatology; however, there are absolutely lessons learned that can be shared if they are adopted and contextualized in different ways. We want to play a role in that space.”

Some examples of innovative approaches include complex innovative trial designs, the use of digital health technologies, model informed drug development (MIDD), patient-focused drug development (PFDD), rare disease endpoint advancement, and the use of real-world evidence. Other examples include AI/Ml programs, decentralized clinical trial design, and efforts to enhance participation from underserved populations.

“I can say that I am the cheerleader for all of these programs, some of which have been around for decades,” said Bugin.

He also discussed the 17 May launch of the program’s Compass Repository, a new data base that includes a list of the center’s clinical trial innovation activities.

Bugin said the database aims to “connect users to information quickly, and to simplify the pathway for interested parties to engage with the FDA's mission of advancing clinical trial innovation.”

Bugin said that the database is “very search friendly” and can be used as “one-stop shopping” for information related to clinical trial innovation at CDER. The database, he said also “has a nice taxonomy and tagging.”

The agency has established some short term and long-terms goals to gauge whether the program has successfully engaged industry in adopting new clinical trial approaches.

In the short term, FDA plans to look at whether the public finds the Compass Repository to be useful, and whether sponsors were able to find the information they were looking for. Another short-term goal is tracking how long users stay on the C3TI and Compass Repository websites. These goals “allow us to evaluate whether we are making progress and whether we are doing the things we said we would do.”

Part of the agency’s long-term goal is to promote three demonstration projects: the Bayesian Supplementary Analysis (BSA) demonstration project, the Selective Safety Data Collection, and the Streamlined Trials Embedded in clinical Practice (STEP) demonstration project.

If selected to participate, sponsors will have the opportunity to frequently engage with CDER staff in addition to the traditional interactions with the review teams.

Through the C3TI program, “FDA has sought to better understand the impact of our clinical trial innovation efforts both internally across CDER and externally,” said Bugin.

REdI meeting

FDA official offers updates on C3TI, knowledge repository

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