Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional) | PAR 25 103

Opportunity Information: Apply for PAR 25 103

The Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional), Funding Opportunity Number PAR-25-103, is a National Institutes of Health cooperative agreement designed to help research teams properly plan cancer prevention and control clinical trials before launching a full-scale study. The central idea is that many trial concepts look strong on paper based on prior literature or early data, but investigators often do not yet have the practical, trial-critical details needed to lock down a final protocol. This program supports the kind of preparatory work that closes those gaps so that later, larger trials can start up faster, run more smoothly, and avoid expensive redesigns midstream.

The scope spans the cancer prevention and control spectrum rather than drug-development treatment trials alone. Projects can focus on improving prevention or interception approaches, changing cancer-related health behaviors, strengthening screening and early detection strategies, improving healthcare delivery and implementation, managing treatment-related symptoms, advancing supportive care, and improving long-term outcomes for cancer survivors. In other words, it targets research that can reduce cancer risk, catch cancers earlier, or improve quality of life and outcomes across the care continuum, including survivorship.

A key motivation behind the U34 mechanism is that even well-justified clinical trial ideas frequently stumble on real-world uncertainties that only become obvious during planning or early execution. Common unknowns include whether the intended population can be identified and recruited efficiently, whether accrual will be achievable at the needed pace, whether the intervention can be delivered consistently across sites or settings, whether endpoints are measurable and meaningful, and whether data collection, statistical assumptions, or operational workflows are realistic. When these issues are not resolved early, protocols often go through repeated changes before and after startup, which can add months of delay, increase costs, and in some cases prevent a trial from finishing successfully. This planning grant is meant to prevent that by paying for targeted preparatory studies and planning activities that make the eventual clinical trial more feasible, efficient, and scientifically solid.

The opportunity also highlights the need to evaluate newer trial designs that reduce infrastructure needs and lower costs, but may require testing for suitability in specific contexts. For example, a more pragmatic or streamlined design might work well in one healthcare setting but fail in another; a remote or hybrid approach might be promising but needs careful feasibility checks for a particular at-risk group; or an endpoint strategy might need refinement for a specific symptom, behavior change program, or community venue. The U34 can support the work needed to vet these design choices so the final trial is ready for implementation with fewer surprises.

Administratively, this is a discretionary funding opportunity using the Cooperative Agreement mechanism, which typically means NIH staff will have a more substantial role than in a standard grant in guiding or coordinating aspects of the project during the award period. The activity category is Education and Health under CFDA 93.399. The posting indicates an original closing date of 2027-10-25 and a creation date of 2024-11-05. Specific award ceiling and expected awards are not listed in the provided source data.

Eligibility is broad and includes many government, academic, nonprofit, and private-sector entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); Native American tribal organizations (other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other categories. Additional eligible applicant types explicitly noted include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), eligible federal agencies, faith-based or community-based organizations, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Indian/Native American Tribal Governments other than federally recognized, non-U.S. (foreign) organizations, regional organizations, Tribally Controlled Colleges and Universities (TCCUs), and U.S. territories or possessions. Overall, the program is positioned to support planning efforts across a wide range of institutions and communities, including those serving populations that are often underrepresented in clinical research.

In practical terms, a strong U34 application under this opportunity would center on a clearly articulated future clinical trial concept in cancer prevention or control, then justify exactly what information is missing to finalize a rigorous, feasible protocol. The planned activities would be focused on filling those gaps (for example, feasibility assessments, recruitment and retention planning, intervention refinement, endpoint validation, data and statistical planning, and operational risk mitigation) so that the subsequent clinical trial can proceed with a high likelihood of timely accrual, clean execution, and interpretable results. The overarching goal is to save time and resources for both investigators and the National Cancer Institute by ensuring that clinical trials in this space start out well designed and ready to run.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.399.
• This funding opportunity was created on 2024-11-05.
• Applicants must submit their applications by 2027-10-25.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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