The FDA, by and through the Center for Drug Evaluation and Research (CDER) announced the new Center for Clinical Trial Innovation (C3TI)[1], to serve as a central hub to support innovative approaches to clinical trials. This will help advance drug development and regulatory decision-making. Existing CDER innovation programs will continue, with C3TI synthesizing lessons learned. C3TI’s mission is to promote clinical trial innovation through enhanced communication and collaboration.
On October 17, 2023, CDER solicited public comments “on the barriers on the barriers and facilitators to incorporating successful on promising innovative clinical trial approaches in drug development programs”. Thereafter a workshop between the public and the FDA, conducted and led by the Duke-Margolis Institute for Health Policy occurred on March 19 & 20th (2024).
Goals and Activities of C3TI
C3TI aims to assist stakeholders in staying current with innovations, improve the efficiency and effectiveness of trials, increase diverse participation, enhance data quality, accelerate drug development, share knowledge across CDER innovation programs, and establish a C3TI Demonstration Program with case examples to spur innovation. Activities include a website, contact email, coordinating information sharing, knowledge repositories, and the demonstration program.
C3TI Demonstration Program
The program allows selected sponsors of innovative pre-IND or IND trials in point-of-care/pragmatic trials, Bayesian analysis, and selective safety data collection to interact with FDA staff. This will provide case examples to share lessons learned and foster innovation across therapeutic areas. Sponsors and the FDA will agree on disclosures before drug approval.
There are three initial project areas for consideration:
- Point-of-care or pragmatic trials
- Bayesian analysis, and
- Trials using selective data collection.
The FDA will seek information from “no more than nine sponsors” for the Demonstration Program.
While the intentions behind the C3TI program are laudable, there remain clinical trial participant privacy concerns. For instance, the new proposed rule contemplates that the C3TI program will “Serve as a central hub for knowledge management and coordinating lessons learned across CDER’s clinical innovation programs”. This may implicate both state and federal privacy considerations that any sponsor or CRO should thoroughly contemplate. Some of the other goals of the program include increasing the participation of diverse populations in clinical trials and enhancing clinical trial innovations.
Finally, plan sponsors will “have the opportunity for enhanced communication and interaction with CDER staff”, which will inevitably lead to a more expedient review of the design of clinical trials. This is an important benefit for any sponsor wishing to efficiently maximize clinical trial protocol innovations and collection of data for related trials. In essence, C3TI contemplates more efficient regulatory reviews like adaptive trials and master protocols. However, the program does not provide funding for innovative clinical trials.
[1] 89 FR 26897 citing Federal Register/Vol. 89, No. 74/Tuesday, April 16, 2024
