Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for research institutions, universities, and medical centers seeking to plan and develop clinical trials focused on cancer prevention and control strategies. Eligible applicants typically include NIH-designated research institutions, academic medical centers, and established clinical research organizations. The program supports the planning phase of clinical trials—not full-scale trial execution—and is designed to help investigators develop rigorous protocols, establish infrastructure, and prepare competitive R01 applications or larger clinical trial grants. Geographic scope is U.S.-based institutions, though some international partnerships may be permitted. Activities supported include protocol development, feasibility assessments, preliminary data collection, infrastructure planning, and team assembly for cancer prevention and control research.
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Program description
The purpose of this NOFO is to facilitate well planned clinical trials across the cancer prevention and control spectrum aimed at improving prevention/ interception, cancer-related health behaviors, screening, early detection, healthcare delivery, management of treatment-related symptoms, supportive care, and the long-term outcomes of cancer survivors. Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, accrual challenges, intervention, outcome/ endpoints, data/statistical challenges or operational risks necessary to finalize the trial protocol completely. These information gaps can result in multiple protocol changes before and after trial start-up, leading to the need for additional time and expenses that may prevent study completion. Further, the suitability and feasibility of new trial designs, which minimize infrastructure and reduce costs may need to be tested in the context of a particular intervention, at-risk group, symptom or venue. Preparatory studies may fill information gaps and address unknowns, improving trial design and knowledge of trial feasibility and thus saving NCI time and money.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- Community Health Center
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Researcher (independent)
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Required documents
- Application forms (SF-424, PHS 398 or electronic submission via eRA Commons)
- Project narrative (not to exceed page limits; check FOA for specific format)
- Detailed budget and budget justification
- Biosketches of key personnel (typically 5-page NIH format for PIs and co-investigators)
- Letters of support from institutional partners, clinical sites, or collaborators
- IRB documentation (exemption determination, approval letter, or protocol outline if not yet submitted)
- Preliminary data or feasibility studies (if available)
- Resource sharing plan (data, materials, software as applicable)
- Other support information (current and pending funding for all key personnel)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.399 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$22,629,848
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$20,187,190
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$19,625,661
-
$19,227,026
-
$18,138,327
-
$17,827,646
-
$17,614,587
-
$16,535,118
-
$16,126,587
-
$14,347,054
Top States by Funding
- NY 7 awards $57.6M
- SC 3 awards $46.6M
- DE 3 awards $43.2M
- IL 3 awards $38.4M
- WI 3 awards $37.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
FAQ
Who is eligible to apply for this grant?
Typically, universities, medical schools, research hospitals, and NIH-recognized research institutions with established clinical research infrastructure. Some grants may require prior NIH funding or demonstrated research experience, though first-time applicants may be competitive with strong preliminary data.
What is the deadline and when can I apply?
Applications open November 5, 2024, with a fixed deadline of October 25, 2027. Check NIH's eRA Commons for the exact submission window, as there may be multiple submission dates throughout the funding period.
What types of activities does this grant support?
This is a planning grant, so funding supports protocol development, feasibility studies, preliminary research, infrastructure setup, and team preparation—not full trial execution. The goal is to strengthen your application for larger clinical trial funding.
How competitive is this program?
U34 grants are moderately competitive. Success typically requires clear scientific rationale, realistic timelines for planning activities, and a credible path to launching a full clinical trial. Strong preliminary data and experienced team leadership increase competitiveness.
What is the typical funding range?
Planning grants typically range from $75,000 to $250,000 total project costs, depending on scope and institutional capacity. Review the most recent funding opportunity announcement (FOA) on grants.nih.gov for exact budget limits and any institutional cost-sharing requirements.
💡 Tips for applicants
- Focus your proposal on cancer prevention or control—not basic science. NIH review panels favor applications addressing real-world clinical and public health needs with direct patient or population benefit.
- Emphasize your planning milestones and deliverables. Clearly lay out what will be completed during the planning period (e.g., finalized protocol, IRB approval, recruitment strategy) so reviewers see a clear path to launching the full trial.
- Highlight your team's clinical trial experience. Even for a planning grant, reviewers want evidence that your investigators have successfully managed prior trials, secured funding, or published trial results. Include a track record section in your bio sketches.
- Include preliminary feasibility data. If you have pilot data on recruitment rates, safety signals, or intervention uptake, include it. Reviewers are more confident funding planning for trials with some empirical foundation.
- Address sustainability and next steps explicitly. Describe your strategy for securing Phase II/III trial funding (R01, U01, CTEP mechanisms, pharma partnerships) so the planning grant appears strategic rather than speculative.
⚠️ Common mistakes
Many applications fail because they lack clear, measurable planning milestones—reviewers see vague language like "develop protocol" without specifying who does what by when. Another common pitfall is underselling the team's clinical trial credentials; a strong basic science record does not guarantee trial management expertise, so explicitly connect prior work to trial planning or execution. Finally, applications often underestimate the scope of work needed in the planning period, leading reviewers to doubt whether the funding level and timeline are realistic.
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