The Biology of Bladder Cancer (R01 Clinical Trial Optional) Notice of Funding Opportunity (NOFO) by the National Cancer Institute (NCI) supports research to understand the biology and mechanisms underlying bladder cancer. Despite progress in molecular profiling and identification of mutations, critical gaps remain in knowledge about the initiation, progression, and heterogeneity of bladder cancer. The initiative invites innovative research addressing these gaps to improve prevention, diagnosis, and treatment strategies. Multidisciplinary approaches are encouraged, including expertise outside bladder cancer to complement the proposed aims.

The NOFO supports projects focused on fundamental biological processes, such as normal bladder development, tumorigenesis, tumor microenvironment, molecular drivers, and disparities across sex, race, or ethnicity. Eligible projects may involve preclinical models, mechanistic studies, or molecular subtype analysis. While clinical trials are optional, projects must emphasize biological inquiry. Studies primarily targeting treatment response, resistance, or immunotherapies are not a priority.

Application budgets are unrestricted but must reflect the needs of the project. The maximum project period is five years. Eligible applicants include higher education institutions, nonprofits, for-profits, government entities, and foreign organizations. Research teams are encouraged to engage collaborators with diverse expertise to enhance the scope and impact of the research.

Applicants should follow NIH submission guidelines and include comprehensive plans for rigor, reproducibility, data sharing, and management. Letters of intent, though not required, are due 30 days before application deadlines, which follow NIH standard due dates (e.g., February 5, June 5, and October 5, 2025). Projects must adhere to NIH policies for data sharing and human subjects protections.

Review criteria emphasize the importance, rigor, feasibility, and innovation of the proposed research, as well as the expertise of the investigators and adequacy of institutional resources. Applications are evaluated for their potential to significantly advance bladder cancer biology, with secondary consideration of budget and resource sharing plans.

For inquiries, applicants may contact program officials specializing in cancer biology, prevention, epidemiology, or financial management. Successful applications will receive funding contingent on scientific merit, relevance to program priorities, and availability of funds. The anticipated earliest start date for awards is December 2025.