FDA launches new clinical trial center to improve innovation, communication
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has launched a new center for internal and external experts to discuss new methods for designing and conducting clinical drug trials, dubbed the Center for Clinical Trial Innovation (C3TI).The center will act as a hub to share lessons learned from its other clinical trial initiatives with the drug development community and is meant to promote clinical trial innovation.
“C3TI will be a central hub within CDER to support the implementation of innovative approaches to clinical trial design and conduct,” said Kevin Bugin, deputy director of operations in the Office of New Drugs (OND) who has been appointed to lead C3TI. “C3TI’s mission is to promote existing and future CDER clinical trial innovation through enhanced communication and collaboration.”
“This will ultimately improve the efficiency of drug development, bringing safe and effective drugs to patients as optimally as possible,” he added in a statement.
CDER Director Patrizia Cavazzoni also posted a video and issued a statement noting the C3TI builds on the CDER’s previous efforts to help innovation in clinical trial design and its own regulatory work to bring new drugs to market, especially those for unmet needs.
She added, “We are eager to build on this foundation by launching C3TI to further spur the adoption of clinical trial innovation across the industry and within CDER.”
Over the past year, FDA has held listening sessions and public workshops on clinical trial innovation. In October 2023, it also opened a docket on Regulations.gov asking stakeholders how the agency could improve the adoption and conduct of new clinical trial designs, which received 30 comments from groups such as PhRMA and BIO and drugmakers such as Eli Lilly and Bayer. The agency said it used all that stakeholder feedback to launch C3TI.
FDA said its other CDER clinical development innovation programs will continue as they are, but C3TI will be used as a forum for compiling lessons from those programs. Ultimately, the agency said C3TI is meant to help improve clinical trial efficiency by sharing lessons learned from those initiatives.
“C3TI will also manage a demonstration program that will expand opportunities for sponsors of innovative clinical trials to interact with CDER staff and for these trials to serve as case examples to spur further implementation,” said FDA.
According to the agency, the first three C3TI demonstration projects will address point-of-care or pragmatic trials, Bayesian analyses, and the use of selective safety data collection in clinical trials. Ultimately, the goal is to help researchers and sponsors stay current on the latest on conducting clinical trials efficiently and improving diversity in trial participants.
In an FAQ page about C3TI, FDA said that the new center will also play an important part in regulatory reviews by helping identify experts in the right kinds of trials, the right clinical trial approach that sponsors should consider, and find ways to help improve clinical trial diversity.
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