Development and Testing of a Multi-use Frameworks Playbook for Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) (U01 Clinical Trial Not Allowed)

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges. The purpose of this NOFO is to solicit applications for the design, development, and preliminary validation of robust frameworks for the application of multimodal-artificial intelligence (AI) models for clinical use. Frameworks developed through these awards would populate a "playbook", defined as a collection of actionable guidelines, standardized protocols, and/or standard operating procedures (SOPs) for reliable and effective development and deployment of multimodal AI tools. It is expected that the frameworks delineated in this playbook will directly address PRIMED-AI objectives and needs, while also remaining flexible enough to enable sufficient extensibility and interoperability for use across a broad spectrum of multimodal biomedical AI applications, both internal and external to the PRIMED-AI Program.

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility. · Foreign Organizations/International Collaborations: Non-domestic (non-U. · S.) Entities (Foreign Organizations) are not eligible to apply. · Non-domestic (non-U. · S.) components of U. · S. Organizations are not eligible to apply. · Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Funding decisions are based on scientific merit (42 CFR 52h) and program relevance. Scientific merit review encompasses: the peer review criteria detailed in the specific funding announcement, as well as the significance, approach, and innovation of the proposed research; the competency of the principal investigator; the adequacy of the resources and environment; the proposed budget and requested period of support; and, where applicable, the adequacy of the measures for protecting against adverse effects upon humans, animals, or the environment.