Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 Clinical Trial Optional)

The National Cancer Institute (NCI) invites applications for early-stage development of informatics technologies through the cooperative agreement funding mechanism (U01) under the "Informatics Technology for Cancer Research" (ITCR) program. This Notice of Funding Opportunity (NOFO), numbered RFA-CA-24-017, supports initial development or substantial modification of informatics tools that address critical needs in cancer research. The grant seeks to improve data acquisition, management, analysis, and dissemination for various aspects of cancer research, including biology, treatment, diagnostics, prevention, epidemiology, and addressing health disparities. The focus is on tools from initial prototyping to enhanced stability and utility, and applicants must demonstrate a strong rationale for their proposed technology and outline methods for engaging users and collecting feedback during the development process. Applicants may submit proposals for new projects, resubmissions, or revisions, with budgets capped at $300,000 in direct costs per year for a maximum project period of three years. The anticipated number of awards ranges from five to six. The NCI expects applicants to describe how their technology will contribute to specific cancer research projects and to the broader field. Examples of eligible technologies include data acquisition software, data processing and integration tools, data visualization platforms, machine learning tools, and clinical decision-support applications. Projects focusing on significant data generation, primarily data analysis, or wet-lab technologies are not eligible for this funding opportunity. To foster collaboration, applicants must set aside 10% of the budget from the second year onward for shared activities with other ITCR projects or external collaborators, pending approval by the ITCR Steering Committee. Additionally, travel funds for annual ITCR program meetings and participation in the ITCR Training Network are required. All projects must include a clear plan for data and software sharing, ensuring open access for research and educational use, and applicants are encouraged to use platforms like GitHub for code dissemination. For machine learning projects, model transparency and documentation for reproducibility are required. Eligible applicants include higher education institutions, nonprofits, for-profits, government entities, and foreign institutions. Multiple applications from a single organization are allowed if each is scientifically distinct. Applicants must complete all required registrations (SAM, eRA Commons, Grants.gov) well in advance. Letters of intent are encouraged and should be submitted 30 days before the due date. Application deadlines are June 11, 2024, and November 15, 2024, and applications must conform to NIH guidelines; late submissions are not permitted. Applications will undergo standard NIH review, focusing on significance, investigator qualifications, innovation, approach, and project environment. For clinical trials, reviewers will assess design, ethical considerations, recruitment plans, and data management. Additional factors include plans for user engagement, tool validation, and milestones. The ITCR Steering Committee, comprising ITCR project leaders and an NCI Project Scientist, will oversee collaborative efforts and distribute set-aside funds for approved joint projects. Funded projects are subject to NIH’s data management and sharing requirements. Annual progress and financial reports are mandatory, and recipients must comply with federal transparency and reporting requirements for grants over $10 million. Successful applicants will retain primary rights to data and software produced, but the NCI will maintain oversight through cooperative agreement terms.