Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R21 Clinical Trials Not Allowed)

The "Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R21 Clinical Trials Not Allowed)" is a funding opportunity reissued by the National Institutes of Health (NIH) through the National Cancer Institute (NCI), with participation from the National Human Genome Research Institute (NHGRI), National Institute on Aging (NIA), and National Institute of Dental and Craniofacial Research (NIDCR). The program seeks to leverage existing clinical, behavioral, genomic, and molecular datasets to conduct innovative secondary data analyses that aim to improve understanding of cancer risk, prevention, survival, treatment response, and other related outcomes. The funding initiative emphasizes the reuse and integration of diverse data types and encourages novel analytical methodologies that address critical gaps in cancer research. This R21 grant opportunity is focused on exploratory and developmental research and does not permit clinical trials. It provides a funding mechanism to support novel ideas or models using pre-existing data, often at a relatively low cost. The NOFO supports interdisciplinary approaches that utilize innovative data modeling, linkage, and harmonization of various existing datasets. Applicants may also include new research aims that are feasible using the available data, propose novel data integration strategies, and assess outcomes relevant to healthcare delivery, behavioral factors, disparities, and survivorship in cancer populations. It aligns with broader NIH data-sharing policies, emphasizing the FAIR (Findable, Accessible, Interoperable, and Reusable) data principles. Funding is limited to a maximum of $275,000 in direct costs over a two-year project period, with no more than $200,000 in any single year. Applications can only allocate up to 10% of the budget for new data generation aimed solely at validating findings. While preliminary data is not required, applications must include a robust and detailed research strategy, including justification for dataset selection, methodological innovation, feasibility, and relevance to underrepresented populations when possible. Projects must not propose new data collection (other than for validation), nor maintain or distribute existing datasets. Proposals must clearly outline the planned analytical methods, dataset characteristics, and relevance to NCI or partner institutes’ goals. Eligible applicants include a wide range of U.S.-based and foreign institutions such as public and private higher education institutions, nonprofits, for-profits, small businesses, state and local governments, tribal governments, public housing authorities, and others. Foreign organizations and non-domestic U.S. components are also eligible. All applicants must complete necessary registrations (SAM, eRA Commons, Grants.gov) before submission, which is strictly enforced by NIH’s electronic systems. Applications are accepted on a rolling basis according to NIH standard due dates until the new expiration date of May 24, 2025. There is no Letter of Intent requirement. Submissions are reviewed under the NIH’s Simplified Review Framework, with scoring based on significance, innovation, investigator expertise, approach, and environment. Post-submission materials must follow NIH guidelines, and selected applicants will receive a Notice of Award (NoA) following successful peer and council review. Program and grants management contacts are available for each participating NIH component, including Dr. Melissa Rotunno (NCI), Dr. Jiayin Li (NCI), Dr. Raquel Sitcheran (NIA), Erin Ramos (NHGRI), and Dr. Noffisat Oki (NIDCR), among others. NIH expects all awardees to broadly share harmonized datasets and tools developed under the grant, consistent with informed consent and NIH sharing policies.