The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has announced the launch of a new hub focused on promoting innovation in clinical trials.
The CDER outlined that its ongoing efforts to support innovation have led to improvements in the design and conduct of clinical trials that are intended to “efficiently generate evidence on the safety and effectiveness of new therapies in ways that meet the growing demands of drug development”.
The creation of the Center for Clinical Trial Innovation (C3TI) comes after the CDER conducted interviews, listening sessions and a public workshop with internal and external parties, and opened a public docket.
“Based on these engagements, we [recognised] an opportunity to enhance the implementation of our innovative efforts and maximise the impact on drug development,” the CDER said.
The C3TI will aim to facilitate the sharing of lessons learned across the CDER’s existing clinical trial innovation initiatives and will communicate and collaborate with external parties.
The new hub will also manage a demonstration programme 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 increase further implementation, the CDER said.
Patrizia Cavazzoni, director of CDER, said: “CDER’s long-standing efforts to embed innovation in clinical trial design and conduct into our regulatory work have been crucial in bringing new therapies to areas of unmet medical need.
“We are eager to build on this foundation by launching C3TI to further spur the adoption of clinical trial innovation across industry and within CDER.”
The C3TI will give internal and external parties easier access to information on clinical trial innovation efforts and allow them to engage in collaborations, find resources that can further support the use of innovative modalities, and identify development programmes where a concerted approach to the use of clinical trial innovations would be impactful.
“The goals of these efforts are to assist those involved in clinical research in staying current with clinical trial innovations, improve the efficiency and effectiveness of clinical trials, help increase the participation of diverse populations in clinical trials, and, in turn, accelerate the development of safe and effective new drugs,” the CDER said.