PRIMED-AI: Validation Center (U54 Clinical Trial Not Allowed) 
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The National Institutes of Health Common Fund and associated institutes are soliciting applications under RFA-RM-27-014 for the Precision Medicine with Artificial Intelligence Integrating Imaging with Multimodal Data program. This initiative focuses on the establishment of a Validation Center to serve as an independent hub for the third party verification, validation, and uncertainty quantification of AI-enabled, image-based, multimodal Clinical Decision Support tools. The primary goal is to develop reliable and cost-effective AI tools that integrate clinical imaging with other health data to improve personalized medicine for patients with chronic and other health conditions. The program utilizes the U54 activity code and specifically targets investigators with expertise in the validation of clinical decision support tools, confidence bounds, and AI prediction failure modes. The Validation Center will be responsible for the systematic retesting and harmonization of deliverables to comprehensively characterize the performance, reliability, reproducibility, generalizability, and interoperability of these tools. This solicitation is managed by the Department of Health and Human Services and is categorized under NAICS code 541715.
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Full Description
The NIH Common Fund, with other NIH Institutes and Centers (ICs), intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for the Precision Medicine with Artificial Intelligence - Integrating Imaging with Multimodal Data (PRIMED-AI) program, which seeks to develop innovative, reliable, and cost-effective AI-based tools that integrate clinical imaging with other health data types to enhance personalized medicine for patients with chronic and other health conditions. The program’s Validation Center initiative will serve as an independent hub for third party verification, validation, and uncertainty quantification of AI-enabled, image-based, multimodal Clinical Decision Support (CDS) tools through the systematic retesting and harmonization of PRIMED-AI deliverables to comprehensively characterize performance of the CDS tools. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the U54 activity code. Investigators with expertise and insights into the validation of CDS tools and the confidence bounds and potential failure modes of AI predictions are encouraged to begin to consider applying for this new NOFO.
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