Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (R01 Clinical Trial Optional)

The NIH's National Cancer Institute (NCI) is reissuing a funding opportunity, "Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies" (PAR-25-145), under the R01 Research Project Grant. This NOFO supports research aimed at understanding and mitigating adverse sequelae from cancer therapies that persist or emerge as chronic or delayed post-treatment effects, which impact the long-term quality of life and health of cancer survivors. By fostering basic, translational, and clinical research, the NOFO seeks to identify the underlying mechanisms of these adverse events, clinically characterize them, and develop therapeutic strategies to prevent or reduce their severity. Applications should focus on adverse effects that are chronic, progressive, or delayed, such as peripheral neuropathy, cardiovascular toxicity, neurocognitive impairments, or immune-related events resulting from cancer treatments. Studies should aim to characterize clinical phenotypes, validate biomarkers, or develop preventive or mitigating interventions based on mechanistic insights. This NOFO encourages studies that address hypotheses with clear mechanistic underpinnings, including human tissue validation for translational relevance. Multidisciplinary collaboration between basic science and clinical researchers is strongly encouraged, with particular emphasis on underserved and understudied populations. Applicants must submit a Plan for Enhancing Diverse Perspectives (PEDP), detailing actionable strategies to integrate diverse scientific perspectives and inclusivity, enhancing the merit of the proposed research. The PEDP will be considered in the scientific merit review and must include defined goals, activities, evaluation methods, and anticipated impacts on inclusivity in the research team and approach. Examples of acceptable PEDP activities include partnerships with diverse institutions, collaborative frameworks that include underrepresented groups, and recruiting diverse study populations. The award budget is flexible to reflect the needs of the proposed project, with no specified cap, but projects requesting $500,000 or more in direct costs for any one year must seek prior approval. The project period is up to five years. Eligible applicants include U.S. and foreign higher education institutions, nonprofits, for-profits, and governments, with allowances for foreign components in U.S.-based projects. Registrations required before application include SAM, NCAGE (if applicable), UEI, eRA Commons, and Grants.gov. Key dates include submission opening on January 5, 2025, with standard NIH submission deadlines and rolling review and award dates. Applications that do not meet the required guidelines or omit the PEDP will be deemed incomplete and withdrawn.