PRIMED-AI: Validation Center (U54 Clinical Trial Not Allowed)

The PRIMED-AI: Validation Center funding opportunity is a forthcoming initiative from the National Institutes of Health (NIH), specifically under the NIH Common Fund and its partnering Institutes and Centers. This program is part of the broader Precision Medicine with Artificial Intelligence (PRIMED-AI) effort, aimed at developing innovative, reliable, and cost-effective AI-based tools that combine clinical imaging with other health data types to advance personalized medicine for patients with chronic and other health conditions. The Validation Center will serve as a key component of the PRIMED-AI program. Its primary role will be to independently verify, validate, and quantify uncertainty in AI-enabled, image-based, multimodal Clinical Decision Support (CDS) tools. This will be achieved by systematically retesting and harmonizing the outputs of the PRIMED-AI program to thoroughly assess the performance of its CDS tools. The initiative emphasizes ensuring the robustness and trustworthiness of AI tools in clinical applications. This opportunity will be administered through a U54 Cooperative Agreement and does not allow for clinical trials. Although applications are not yet being accepted, this forecast is intended to give potential applicants ample time to prepare collaborative and responsive proposals. The NIH encourages investigators with expertise in validation methodologies, AI prediction confidence bounds, and the identification of failure modes in AI systems to begin considering applications. Eligible applicants include a wide range of entities such as public and private higher education institutions, independent school districts, Native American tribal entities, small and for-profit businesses, nonprofits, county governments, and public housing authorities. There is no cost-sharing or matching requirement. The estimated total funding for this opportunity is $3.9 million. The notice forecasts an estimated posting date of July 1, 2025, with applications due by November 1, 2025. Awards are expected to be announced by September 1, 2026, with projects commencing on the same date. For additional information, potential applicants may contact Sahana N. Kukke, PhD, at the NIH Office of the Director via email at [email protected] or by phone at 301-402-3756.

Applicants are encouraged to begin forming collaborations and projects early, particularly those with relevant expertise in AI validation and CDS tool analysis.