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.Apply for PAR 25 103
- 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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Frequently Asked Questions (FAQs)
What is the Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional)?
It is a National Institutes of Health (NIH) cooperative agreement program designed to fund the planning work needed to prepare a cancer prevention and control clinical trial for successful launch. The purpose is to help research teams resolve practical, trial-critical unknowns so the eventual full-scale study can start faster, operate more smoothly, and avoid costly redesigns after the trial is underway.
What is the funding opportunity number for this program?
The Funding Opportunity Number (FON) is PAR-25-103.
What does the U34 planning grant support, in plain terms?
The U34 supports targeted preparatory work that closes the gap between a promising trial concept and a finalized, workable clinical trial protocol. Many ideas look strong based on prior literature or early data, but still lack key operational details. This program funds the work needed to lock down those details before launching a larger trial.
Why does NIH fund planning grants like this instead of only funding the full clinical trial?
Because real-world uncertainties often only become obvious during planning or early execution. If they are not addressed early, protocols can require repeated changes before and after startup, causing delays, increased costs, and sometimes trial failure. The planning grant is meant to reduce those risks by helping investigators identify and solve feasibility and design issues upfront.
What types of research are within scope for this opportunity?
The scope spans the cancer prevention and control spectrum. It is not limited to drug-development treatment trials. Projects can focus on prevention or interception approaches, cancer-related health behavior change, screening and early detection, healthcare delivery and implementation, management of treatment-related symptoms, supportive care, and improving outcomes for cancer survivors.
Does this program cover survivorship-related research?
Yes. The opportunity explicitly includes improving long-term outcomes for cancer survivors and work across the care continuum, including survivorship.
Is this planning grant meant for treatment drug development trials?
The emphasis is on cancer prevention and control rather than treatment drug-development trials alone. The program is positioned to support planning for trials that reduce cancer risk, catch cancers earlier, improve healthcare delivery, improve quality of life, and improve outcomes across prevention, screening, care delivery, symptom management, supportive care, and survivorship.
What kinds of "unknowns" or gaps is the U34 intended to address?
The opportunity highlights common trial-stopping uncertainties such as whether the intended population can be identified and recruited efficiently, whether accrual can be achieved 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 plans, statistical assumptions, and operational workflows are realistic.
How can this U34 help reduce delays and costs for a future trial?
By funding planning activities that reduce the need for repeated protocol changes and redesigns during startup or after the trial begins. Better upfront planning can prevent months of delays, reduce expensive midstream revisions, and improve the likelihood that the trial finishes successfully with interpretable results.
Does the U34 support feasibility assessments and pilot-type planning work?
Yes. The description emphasizes targeted preparatory studies and planning activities, including feasibility assessments, to ensure the trial is realistic and implementable before committing to a full-scale study.
What are examples of planning activities that could be supported?
Examples mentioned include feasibility assessments, recruitment and retention planning, intervention refinement, endpoint validation or refinement, data and statistical planning, and operational risk mitigation designed to support a rigorous and feasible final protocol.
Can the U34 be used to evaluate or vet newer trial designs?
Yes. The opportunity specifically highlights the need to evaluate newer trial designs that may reduce infrastructure needs and lower costs but require testing for suitability in specific contexts.
What kinds of newer trial design questions might be addressed during the planning period?
Examples include whether a pragmatic or streamlined design will work in a given healthcare setting, whether a remote or hybrid approach is feasible for a specific at-risk group, and whether an endpoint strategy needs refinement for a particular symptom, behavior change program, or community venue.
What is the award mechanism, and why does it matter?
This opportunity uses a Cooperative Agreement mechanism. That 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.
Is this funding opportunity discretionary?
Yes. It is described as a discretionary funding opportunity.
Which NIH institute is associated with the goals described here?
The program is positioned to save time and resources for investigators and the National Cancer Institute by ensuring trials in this space start well designed and ready to run.
What is the activity category and CFDA number listed for this opportunity?
The activity category is Education and Health, and the CFDA listing provided is 93.399.
When was this opportunity created, and what is the closing date listed?
The creation date listed is 2024-11-05, and the original closing date listed is 2027-10-25.
Is an award ceiling or the expected number of awards provided?
No. The provided source data does not list a specific award ceiling or the expected number of awards.
Who is eligible to apply?
Eligibility is broad. The opportunity includes many government, academic, nonprofit, and private-sector entities, including 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.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly included among the eligible applicant types noted.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-U.S. (foreign) organizations are explicitly noted as eligible applicant types.
Are federally recognized tribal governments eligible?
Yes. Native American tribal governments (federally recognized) are listed as eligible applicants.
Are tribal organizations that are not federally recognized eligible?
Yes. Native American tribal organizations (other than federally recognized tribal governments) are listed as eligible, and the additional eligibility list also notes Indian/Native American Tribal Governments other than federally recognized.
Are small businesses eligible to apply?
Yes. Small businesses are listed among eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible applicants, and small businesses are also eligible.
Are nonprofits required to have 501(c)(3) status to apply?
No. The eligibility list includes nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (other than institutions of higher education).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly noted among additional eligible applicant types.
Are Minority Serving Institutions included in eligibility?
Yes. The opportunity explicitly notes several types, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
Are eligible federal agencies allowed to apply?
Yes. Eligible federal agencies are explicitly noted among additional eligible applicant types.
What would a strong U34 application emphasize?
A strong application would present a clearly articulated future clinical trial concept in cancer prevention or control, explain what information is missing to finalize a rigorous and feasible protocol, and propose focused planning activities to fill those gaps so the later trial can proceed with a high likelihood of timely accrual, clean execution, and interpretable results.
Is this program intended to fund the full clinical trial?
The description provided focuses on funding the planning work that occurs before launching a full-scale trial, with the goal of preparing for a later, larger clinical trial. The emphasis is on protocol-finalizing activities rather than running the full-scale study itself.
How does this program define success for the planning period?
Based on the description, success means resolving key feasibility and design uncertainties and producing a trial-ready protocol and operational plan that reduces surprises, supports consistent delivery across sites/settings, enables realistic accrual, and improves the chance that the later clinical trial runs efficiently and yields interpretable results.
What is the overall goal of the program?
The overarching goal is to save time and resources for both investigators and the National Cancer Institute by ensuring cancer prevention and control clinical trials start well designed and ready to run, with fewer delays and less risk of costly midstream redesigns.
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