PRIMED-AI: Translating Models to Clinic (UG3/UH3 Clinical Trial Optional)

The National Institutes of Health (NIH), through its Common Fund and with participation from other NIH Institutes and Centers, is preparing to launch a funding initiative titled “PRIMED-AI: Translating Models to Clinic” under opportunity number NOT-RM-25-023. This effort falls under the broader Precision Medicine with Artificial Intelligence program, also known as PRIMED-AI. The goal of this initiative is to enhance patient-specific healthcare interventions by leveraging artificial intelligence (AI) technologies that combine clinical imaging with other types of health data. The initiative targets the development and validation of AI-based tools that offer improved diagnostic accuracy, better prognostic predictions, and effective therapeutic guidance, especially in chronic or complex health conditions where current methods underperform. The PRIMED-AI: Translating Models to Clinic program will utilize a UG3/UH3 cooperative agreement mechanism that facilitates a phased approach. The UG3 phase will emphasize model development through retrospective analyses of large and interoperable multimodal datasets. This initial phase is focused on building reliable AI models and ensuring they are robust across diverse patient datasets. For projects that show strong foundational results and readiness, the second phase (UH3) will assess the real-world clinical utility of the developed AI models, particularly as clinical decision support (CDS) tools within healthcare environments. The anticipated total program funding is approximately $10.2 million, although specific ceilings and floors for individual awards have not yet been specified. The number of expected awards is also unspecified. Cost-sharing or matching funds are not required to participate in this opportunity. Funding is discretionary and is designed to encourage scientific innovation in AI applications within medicine. Eligible applicants include a wide range of entities such as public and private institutions of higher education, state and county governments, independent school districts, small businesses, for-profit entities other than small businesses, Native American tribal governments and organizations, public housing authorities, and nonprofit organizations with 501(c)(3) status, excluding higher education institutions. As this is a forecasted opportunity, applications are not currently being accepted. The estimated posting date for the Notice of Funding Opportunity (NOFO) is July 1, 2025. Following that, the estimated application due date is November 1, 2025. Award notifications are expected to be made by September 1, 2026, which is also the anticipated project start date. This opportunity will be open to applicants nationwide with no geographic restrictions. The NIH encourages researchers and organizations with expertise in managing and analyzing large-scale multimodal datasets to begin forming partnerships and developing project concepts in preparation for the upcoming solicitation. The NIH emphasizes that the goal of the forecast is to give potential applicants adequate time to prepare competitive and compliant applications once the NOFO is released. This initiative falls under the Assistance Listing Number 93.310, which pertains to Trans-NIH Research Support. For further information or pre-submission inquiries, interested parties can contact Dr. Sahana N. Kukke at the NIH Office of the Director. She can be reached by phone at 301-402-3756 or by email at ODPRIMED-AI@od.nih.gov. The NIH encourages early communication for clarification and collaboration-building before the solicitation is officially published.

Notice recommends that interested parties begin forming collaborations and preparing proposals early.