The purpose of this Notice is to inform applicants of one of the topic areas for the June 21, 2022 due date of the NCATS CTSA Program funding opportunity announcement (FOA) PAR-22-122, Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional).
Through this notice, NCATS will support applications for Clinical and Translational Science Award (CTSA) Program consortium-wide resource centers that will rapidly demonstrate and disseminate innovative resources (to include capabilities) that have demonstrated impact at a local or national level to the wider consortium. Applicants must address the topic areas described below.
In July 2016, NCATS established the Trial Innovation Network (TIN) with three Trial Innovation Centers (TICs) and one Recruitment Innovation Center (RIC). The TICs were established to transform the CTSA network’s ability to implement multi-site studies by adding innovative network capacity to the existing strengths at the CTSA Hubs. The RIC was focused on implementing successful, evidence-based recruitment and retention strategies to improve both the quality of clinical trials and the value of research to all Americans. The RIC works in partnership with researchers/study teams to provide tailored support and advice to enhance recruitment and retention for individual studies. The RIC, in collaboration with Hub liaison teams (HLT) at each CTSA Hub, provides access to millions of possible participants for research studies, resources and expertise within the CTSA network for NIH- and federally supported clinical studies as well as clinical trials conducted by the private and non-profit sectors.
The TIN has established processes for interactions between CTSA investigators and TIN liaison teams, consultations on clinical trial proposals, recruitment and retention strategies, single IRB coordination and review, and site identification and assessment. In addition, the TIN maintains an electronic toolbox of clinical trial resources and disseminates best practices/methods for conducting clinical trials and clinical research studies through Collaboration Webinars.
The goal of this Notice of Special Interest (NOSI) is to solicit applications for the June 21, 2022 receipt date of the NCATS CTSA Program funding opportunity announcement (FOA) PAR-22-122, Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional). NCATS seeks to fund the activity to identify innovative, effective and efficient approaches to research participant recruitment and retention across the CTSA network and to serve as a national model for effective recruitment and retention in clinical trials. The RICs are expected to demonstrate and disseminate innovative solutions that can be successfully applied to accelerate research participant recruitment and retention. The RICs are expected to work in partnership with each other, the TICs, and individual CTSA hubs to improve the implementation of multi-site studies across the CTSA network.
The primary objective of the RICs is to provide evidence-based strategies to enhance participant recruitment and retention in clinical trials and studies, including addressing ways to enhance diversity, equity and inclusion of all populations enrolled in the study. Strategies should begin during the planning phase of the study and extend beyond the implementation phase to consider dissemination and communication of trial results to participants and accelerate the successful completion of multi-site trials including the diversity of those enrolled. The lack of participant diversity in many clinical trials and studies—despite increasing diversity in the US—jeopardizes the generalizability of study findings, increases the risk of perpetuating and exacerbating health disparities and decreases the quality of health care for all. Overcoming this translational science challenge is crucial to reducing disparities and advancing health equity. Barriers to clinical trial participant diversity, such as medical mistrust; trial availability, access, eligibility, and enrollment practices; and negative beliefs, norms, and attitudes, present substantial challenges—and yet, they are modifiable (Gray, Darrell II, Diversity in Clinical Trials; An opportunity and imperative for Community Engagement Lancet 2021, Vol. 6. Issue 8, p605-607.)
The focus of this initiative is to improve recruitment into trials and build trust with communities not currently participating in clinical research. Note that there may be observational studies that could benefit from innovations in recruitment and retention so that the term “multi-site trial” in this NOSI is used in a broad sense for interventional and observational research studies. Single-site studies are not the focus of the TIN. However, it is anticipated that the new tools and approaches created will be generalizable to widely benefit trials, and ultimately clinical practice.