On May 15 and June 5, 2015, NCATS released two new Clinical and Translational Science Awards (CTSA) program funding opportunity announcements (FOAs), one for Recruitment Innovation Centers (RICs) and the other for Trial Innovation Centers (TICs). Both are aimed at overcoming key roadblocks to multisite clinical trials. CTSA hubs form a national network of medical research institutions that work together to improve the translational research process.
Conducting multisite clinical research in the United States often is associated with implementation delays and high costs. This is due in part to long-standing challenges, such as historically low trial participant recruitment; complexity of obtaining approval of a single protocol by multiple institutional review boards; and few standards for executing research contracts, qualifying clinical sites and initiating study start-up procedures.
“Through these new FOAs, NCATS is addressing systemic problems in translation and contributing to a collaborative national network for translational medicine,” said NCATS Director Christopher P. Austin, M.D. “These improvements are aimed at dramatically accelerating the clinical translational process and getting more treatments to more patients more quickly.”
CTSA hubs collaborate to support high-quality clinical and translational research locally, regionally and nationally, fostering innovation in training, patient involvement and new methodologies. The CTSA program RICs (RFA-TR-15-004) and TICs (RFA-TR-15-002) will transform multisite clinical research by reducing delays in trial start-up, accelerating participant recruitment and standardizing certain business processes across the CTSA hubs.
RIC applications are due July 22, 2015, and letters of intent are due on June 22, 2015. TIC applications are due Sept. 15, 2015, with letters of intent due on Aug. 15, 2015.
“Efficient implementation of multisite clinical trials is crucial for successful translation of fundamental discoveries into patient benefit,” said Petra Kaufmann, M.D., M.Sc., NCATS director of clinical innovation. “These FOAs will not only enhance the overall conduct of clinical trials, but also help increase participation by underrepresented populations in clinical research, such as children, the elderly and minority populations.”
TICs will serve as lead centers of excellence to facilitate multisite clinical trial implementation within the CTSA network. The primary objective of the TICs is to develop, demonstrate and disseminate innovative ways to increase the quality and efficiency of multisite clinical research. TICs will explore innovative approaches in streamlining trial implementation, promoting high-quality multisite trials and disseminating best practices. With these seven-year awards, NCATS anticipates spending $12 million in fiscal year (FY) 2016 to fund three TICs in response to the FOA, depending on the availability of funds. The National Institute on Aging will co-fund the TICs.
The purpose of the RICs is to increase the likelihood of success for multisite clinical trials in two ways: (1) by developing informatics-driven approaches to assessing the site-specific availability of potential participants during trial planning and (2) by developing innovative approaches to participant recruitment during trial implementation. For these five-year awards, NCATS plans to fund up to two RICs in FY 2016 with up to $3 million each in total costs. The two RIC centers will work together with individual CTSA hubs to ensure that informatics approaches used to conduct feasibility assessments accurately reflect the local electronic health record environment, and that the collaboratively developed recruitment strategies are well-aligned with the local CTSA ethical and regulatory environment. The National Library of Medicine will co-fund the RICs.
In developing the FOAs, NCATS carefully considered input about the CTSA program from the Institute of Medicine, a working group of the NCATS Advisory Council (PDF - 414KB), CTSA investigators, patient groups, other NIH Institutes and Centers, biotechnology and pharmaceutical development organizations, regulatory agencies, and the broader clinical and translational research community.
Learn more by visiting the CTSA Funding Information page.
Posted June 2015