Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)

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Description

This opportunity, offered by the National Cancer Institute (NCI) at NIH, supports investigator-initiated clinical trials (R01 mechanism, clinical trial required) that aim to reduce the burden of cancer. The focus is on prevention, early detection, screening, interception, healthcare delivery, quality of life, and survivorship. The program is not intended for trials of cancer diagnosis or oncologic therapy in patients.

The supported trials should have the potential to improve clinical practice and/or public health and must align with the programmatic interests of the NCI Division of Cancer Prevention and/or the NCI Division of Cancer Control and Population Sciences.

Areas of Research

Relevant research areas include, but are not limited to:

• Cancer prevention and interception: Interventions to block, reverse, or delay early cancer stages, including behavioral, dietary, pharmacologic, or surgical approaches.
• Cancer screening and early detection: Studies on new or improved technologies, biomarkers, or practices for early cancer detection and risk assessment.
• Behavioral research: Interventions targeting risk behaviors (e.g., tobacco, alcohol, sun exposure), vaccine uptake, screening adherence, and psychosocial processes.
• Implementation science: Strategies to promote adoption and sustainability of evidence-based interventions in healthcare or public health settings.
• Healthcare delivery: Interventions to improve organization or delivery of cancer care, including team-based care, patient navigation, and survivorship programs.
• Cancer survivorship: Interventions to address physical, psychological, social, or financial burdens among survivors and their families.
• Supportive and palliative care: Interventions for prevention or treatment of symptoms and morbidities related to cancer and its treatment.
• Quality of life: Studies to improve patient quality of life.

Note: Observational studies and trials of cancer diagnosis or oncologic therapy in patients are not eligible under this NOFO.

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Due Dates

• Standard NIH R01 due dates apply.

• Upcoming deadlines:

  • June 5, 2025 (New applications)
  • July 5, 2025 (Renewal/Resubmission/Revision)
  • September 7, 2025 (AIDS-related applications)
  • October 5, 2025 (New)
  • November 5, 2025 (Renewal/Resubmission/Revision)
  • January 7, 2026 (AIDS)
  • Additional cycles through January 2027

• Letter of Intent: 30 days prior to the application due date (optional but encouraged).

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Funding Amount

• Budget: No specific budget cap; budgets must be well-justified and reflect the actual needs of the proposed project.
• Project period: Up to 5 years.
• Number of awards: Contingent on NIH appropriations and the number of meritorious applications.

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Eligibility

Eligible applicants include:

• Public and private institutions of higher education
• Nonprofits (with or without 501(c)(3) status)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Independent school districts
• Public housing authorities/Indian housing authorities
• Native American tribal governments and organizations (federally recognized and other)
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Non-domestic (non-U.S.) entities (foreign organizations) and foreign components of U.S. organizations

Individuals: Any qualified individual(s) with the skills, knowledge, and resources to carry out the proposed research may apply.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Required registrations: All applicant organizations must have active registrations in SAM, eRA Commons, and Grants.gov. PD/PIs must have an eRA Commons account.
• Application instructions: Follow the NIH SF424 (R&R) Application Guide and the specific instructions in the funding announcement.
• Clinical trial requirements: Applications must include all required clinical trial documentation, including a detailed protocol synopsis, statistical design and power calculations, data and safety monitoring plan, and a study timeline with milestones.
• Data Management and Sharing Plan: Required for all applications generating scientific data.
• Budget: No cap, but must be justified. If requesting $500,000 or more in direct costs in any year, applicants must contact a program officer at least 8 weeks before submission.

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Additional Information

• Non-responsive applications: Trials of cancer diagnosis or oncologic therapy in patients, and certain Phase III trials (see NOFO for details), are not eligible.
• Contact with NCI staff: Strongly encouraged to contact NCI program staff at least 12 weeks before the due date to discuss the fit and appropriateness of the proposed trial.
• Review criteria: Scientific merit, significance, innovation, approach, investigator expertise, and environment. See the NOFO for detailed review criteria.
• Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required.

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External Links

• Full Funding Announcement (PAR-25-167)
• NIH Grants & Funding Main Page
• NCI Division of Cancer Prevention
• NCI Division of Cancer Control and Population Sciences
• NIH Application Guide
• Apply via Grants.gov

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Contact Information

For additional contacts, see Section VII. Agency Contacts in the NOFO.