Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for biomedical researchers and research institutions seeking to conduct clinical trials focused on cancer prevention and control interventions. Eligible applicants include research universities, medical schools, hospital research departments, academic medical centers, and NIH-funded research organizations. This program supports Phase II and Phase III clinical trial research that advances evidence-based cancer prevention or control strategies. While funding can support various trial designs, applicants must demonstrate institutional research infrastructure, qualified clinical investigator teams, and IRB approval capacity. Geographic scope is nationwide, and both individual researchers with appropriate doctoral degrees and established research programs may apply, though institutional affiliation is typically required.
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Program description
Through this notice of funding opportunity (NOFO), the National Cancer Institute (NCI) invites applications for support of investigator-initiated clinical trials that have the potential to reduce the burden of cancer through improvements in early detection, screening, prevention and interception, healthcare delivery, quality of life, and/or survivorship related to cancer; with such attributes, the proposed studies should also have the potential to improve clinical practice and/or public health. Applications submitted to this NOFO must include studies that meet the National Institutes of Health (NIH) definition of a clinical trial (see NOT-OD-15-015 for details) and provide specific clinical trial information as described in this FOA. This NOFO does not and will not support clinical trials for studies of cancer diagnosis and/or oncologic therapy in patients. The proposed investigator-initiated projects should be related to the programmatic interests of the NCI Division of Cancer Prevention and/or the NCI Division of Cancer Control and Population Sciences.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) form and SF-424 (R&R) Cover Page Supplement
- Project Narrative (specific aims, research design, methods, timeline)
- Biographical Sketches (lead PI and key personnel, NIH format)
- Budget Justification with detailed budget narrative
- Institutional Support Letter/Commitment documentation
- IRB approval letter or evidence of IRB review plan
- Clinical Trial Protocol or detailed protocol synopsis
- Data Safety Monitoring Board plan (for Phase III trials)
- Letters of Commitment from collaborating sites or clinical partners
- Bibliography and References Cited
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
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$19,227,026
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$18,138,327
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$17,827,646
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$17,614,587
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$16,535,118
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$16,126,587
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$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 R01 clinical trial grant?
Researchers with a doctoral degree (PhD, MD, DDS, DVM, or equivalent) at research institutions including universities, medical schools, hospitals, and NIH-funded research centers. Your institution must have established research administration and IRB capacity.
Is a clinical trial required?
Yes. This specific R01 requires that your proposed research includes human subjects clinical trial activities. Observational studies or preclinical work alone are not supported under this mechanism.
What is the typical funding range and timeline?
R01 grants for clinical trials typically support 3-5 year projects. Funding amounts vary based on research scope, but NIH cancer grants commonly range from $200,000-$500,000+ annually, depending on the trial's complexity and patient population.
What makes an application competitive?
Strong competitive applications include well-designed trial protocols, preliminary data supporting feasibility, experienced research teams, realistic recruitment strategies, and clear cancer prevention or control outcomes. Reviewer concern often focuses on study design rigor and team qualifications.
When are applications due and how long is the review process?
The fixed deadline for this cycle is January 7, 2027. The standard NIH review process takes approximately 6-9 months from submission to funding notification, with peer review followed by program officer evaluation.
💡 Tips for applicants
- Invest significant time in your study design and statistical power calculations. Reviewers scrutinize clinical trial methodology heavily, so justified sample sizes and analysis plans are critical to a strong application.
- Build in detailed recruitment and retention strategies with realistic timelines. Most reviewer critiques of clinical trial applications cite insufficient planning for patient enrollment or high dropout rates; demonstrate you've thought through site selection, patient populations, and retention incentives.
- Establish team expertise clearly and early. Highlight your clinical investigator's trial experience, biostatistician credentials, and any patient or community advisory board involvement that strengthens credibility.
- Include preliminary data or feasibility studies that demonstrate your intervention is ready for Phase II/III testing. Reviewers want evidence that you've moved beyond early-stage development.
- Plan for data management, safety monitoring, and regulatory compliance transparently. Describe your DSMB (Data Safety Monitoring Board) structure, adverse event tracking, and institutional oversight capacity to show you understand clinical trial governance.
⚠️ Common mistakes
Applications are commonly rejected when study designs lack adequate statistical power, sample sizes are unrealistic relative to enrollment timelines, or preliminary feasibility data is missing. Another frequent issue is insufficient detail on recruitment strategy, retention methods, or team qualifications—reviewers need to see evidence that the team has successfully completed similar trials. Additionally, poor alignment between the proposed intervention and cancer prevention/control outcomes, or proposing a study that is primarily observational rather than interventional, will result in out-of-scope determinations.
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