Biology of Bladder Cancer (R21 Clinical Trial Optional)

The National Cancer Institute (NCI) invites applications for the Biology of Bladder Cancer initiative, aimed at advancing the understanding of bladder cancer mechanisms and biology. Bladder cancer presents a significant health burden due to its high incidence, frequent recurrence, and the limited survival rates of late-stage diagnoses. This funding opportunity, using the R21 mechanism, supports exploratory research into molecular, cellular, and environmental aspects of bladder cancer, offering insights that could lead to new preventative or therapeutic interventions. Applications may propose clinical trials, but only as related to non-muscle-invasive bladder cancer (NMIBC). Key research priorities include understanding normal bladder biology and its alteration in cancer, identifying drivers of NMIBC recurrence and progression to muscle-invasive bladder cancer (MIBC), exploring the tumor microenvironment, investigating biological disparities based on sex or race, and developing novel models for studying bladder cancer. Applications emphasizing molecular mechanisms, subtype biology, or the role of the microbiome are particularly encouraged. Projects that focus on therapeutic trials for MIBC, immunotherapy resistance, or predominantly translational aims will not be considered responsive. Eligible applicants include higher education institutions, nonprofits, small businesses, local and tribal governments, and foreign organizations. Researchers with expertise outside of bladder cancer are encouraged to collaborate to broaden the scientific impact. Applications must follow NIH’s updated application forms (FORMS-I), available from January 16, 2025, with deadlines of February 16 and June 16, 2025. Letters of intent are optional but recommended to assist with workload planning. The maximum direct cost budget for a two-year project is $275,000, with no more than $200,000 allowed in a single year. The research period may not exceed two years. The application must comply with NIH guidelines, including a Data Management and Sharing Plan, and follow NIH’s rigor and transparency principles. Successful applications will advance the understanding of bladder cancer biology, addressing critical gaps that could inform future clinical practices. Applications will be evaluated based on their significance, innovation, approach, and feasibility, along with the investigators’ expertise and institutional support. Review criteria will also consider the proposed project’s potential impact on bladder cancer biology and the alignment of methodologies with the project’s goals. For further inquiries, applicants may contact designated program officers at the NCI.