NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required)

The National Institute on Aging (NIA) is offering grants for multi-site clinical trials through the NIA Multi-site Clinical Trial Implementation Grant (PAR-25-222). This funding opportunity supports interventional clinical trials at all stages related to aging and conditions affecting older adults, aiming to advance understanding in biomedical, behavioral, and social sciences related to aging. Proposals should target complex health issues in aging populations, such as multimorbidity and polypharmacy, while ensuring ethical standards for informed consent and accommodating potential cognitive and physical challenges among older participants. The program encourages applicants to design trials that address the unique needs and health challenges of older adults, including those with multiple chronic conditions. Applicants are expected to conduct trials that contribute to the evidence base for health issues relevant to the NIA mission. Trials should be thoroughly planned and ready for implementation upon award, as the NOFO does not cover clinical trial planning. Applicants proposing a single-site clinical trial should instead refer to the NIH Parent R01 Announcement for Clinical Trial Required projects. Applicants must prepare detailed scientific and operational plans, including budgetary provisions for data management, independent study monitoring, regulatory submissions, and safety oversight. Additionally, applicants should demonstrate expertise in managing issues related to the older population, such as managing informed consent from those with potential cognitive vulnerabilities, recruiting frail individuals, and ensuring diverse representation. Trial organizers are also required to interface with NIA's Clinical Research Operations Management System (CROMS) for standardized data management. Eligible organizations include U.S. and foreign institutions of higher education, nonprofit and for-profit organizations, government entities, and certain other entities. The budget is flexible, with a maximum project period of five years. Applicants must register in required systems, including SAM, Grants.gov, and eRA Commons, before submission. Those seeking $500,000 or more in direct costs annually must contact an NIA Scientific/Research officer at least six weeks before submission. Review criteria focus on the significance and innovation of the research, rigor and feasibility of the proposed methodology, and the expertise and resources available to the project team. Applications will be evaluated for scientific merit by NIA-convened review groups, and those scoring highest will proceed to further review stages. Awards will be made based on scientific merit, fund availability, and alignment with NIA priorities, with award notices provided through the eRA Commons system. Data management and sharing plans must comply with NIH policies, and final reporting, including progress and financial reports, is required annually and upon project completion. For inquiries, applicants can contact specific NIA representatives listed in the NOFO for guidance on application submission, scientific questions, or financial management.