Validation Center for Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) (U54 Clinical Trials Not Allowed)

The Validation Center for Precision Medicine with AI: Integrating Imaging with Multimodal Data program is a federal funding opportunity administered by the National Institutes of Health through the Office of Strategic Coordination within the Common Fund. This initiative is part of a broader effort to advance biomedical discovery and translate research into clinical applications. The program specifically supports the development of artificial intelligence driven clinical decision support tools that integrate imaging data with other multimodal health data. The Validation Center is intended to function as a central hub within the larger PRIMED AI Consortium, ensuring that tools developed across the program are rigorously evaluated for reliability, reproducibility, and clinical applicability. The primary purpose of this funding opportunity is to establish a Validation Center that conducts comprehensive verification and validation of AI based clinical decision support tools. These tools are expected to integrate imaging with clinical, biological, and other health related datasets to improve patient outcomes. The Validation Center is responsible for evaluating model performance, ensuring interoperability, and quantifying uncertainty. It will also maintain benchmark datasets and make validated results publicly available through a centralized portal. This supports transparency and promotes broader adoption of validated tools across the healthcare system. Funding supports a cooperative agreement mechanism with substantial federal involvement. The program anticipates a single award with significant financial investment over a five year project period. Applicants are expected to propose budgets aligned with project needs, with direct cost limits specified for each project year. Funds may be used for personnel, data management, validation infrastructure, collaborative activities, and development of benchmarking tools. The program does not require cost sharing, and clinical trials are not allowed under this funding opportunity. Eligibility for this grant is broad and includes higher education institutions, nonprofits, for profit organizations, and various levels of government entities within the United States. Foreign organizations and non domestic components are not eligible. Applicants must meet federal registration requirements including SAM, Grants.gov, and eRA Commons. Applications must be submitted electronically through approved systems such as NIH ASSIST or institutional system to system solutions. The application must follow multi project structure requirements and include detailed plans for validation, translation, and fast track cores. The application process requires adherence to NIH submission guidelines and includes structured components such as research strategy, milestone planning, data management plans, and evaluation frameworks. Applicants must define measurable milestones, propose validation methodologies, and outline collaboration strategies with other consortium participants. Evaluation criteria focus on scientific merit, innovation, feasibility, and the ability to contribute to clinical adoption of AI tools. Applications undergo peer review followed by advisory council review before funding decisions are made. The timeline for this opportunity includes an opening date in early September with a firm application deadline in early October. Review and award processes extend into the following year, with anticipated project start dates in mid year. Applicants are encouraged to submit early to allow for corrections. The opportunity does not explicitly state recurring cycles, suggesting it may be a one time or limited cycle funding announcement. Contact information is provided through NIH program email channels for scientific, review, and administrative inquiries.

Focus on rigorous validation methodology clear milestone planning and strong collaboration strategy aligned with consortium goals