Cancer Prevention and Control Clinical Trials Planning Grant Program (R34 Clinical Trials Optional)

The Cancer Prevention and Control Clinical Trials Planning Grant Program (R34 Clinical Trials Optional) is a funding opportunity issued by the National Cancer Institute (NCI), a component of the National Institutes of Health (NIH), under the U.S. Department of Health and Human Services. This program is designed to support the planning phase of cancer prevention and control clinical trials, enabling researchers to gather critical data necessary to finalize protocols for full-scale multi-center Phase II or later-phase trials. It replaces the earlier PAR-22-173 and is guided by updated priorities as of March 31, 2025. This funding initiative aims to reduce operational and scientific uncertainty in clinical trial design, helping to address common challenges such as limited data on specific interventions, study populations, or recruitment strategies. By funding preparatory studies, the NCI seeks to improve the feasibility, rigor, and cost-efficiency of future trials. The R34 mechanism differs from other planning grants in that it does not support the generation of new efficacy or effectiveness data, but rather supports feasibility-related planning activities. These may include pilot/feasibility trials, data modeling, statistical design, and standardization of procedures or instruments. Projects eligible for this funding must align with the missions of either the Division of Cancer Prevention or the Division of Cancer Control and Population Sciences. Research areas include cancer prevention and interception, behavioral health interventions related to cancer risk factors, screening and early detection strategies, healthcare delivery models, survivorship care, supportive and palliative care, and quality-of-life improvements for cancer patients. The program supports pilot studies, feasibility assessments, and planning activities, but excludes first-in-human studies, purely mechanistic work, animal studies, or applications lacking a milestone plan or preliminary justification for the future trial. Eligible applicants include a broad array of U.S. and international entities, such as higher education institutions, nonprofits, small and large businesses, state and local governments, tribal organizations, and foreign institutions. The maximum project period is three years, and funding is limited to $225,000 in direct costs per year. The total ceiling is $450,000 for non-clinical-trial applications and $600,000 if a pilot/feasibility clinical trial is included. No cost-sharing is required. Applicants may submit multiple scientifically distinct applications. Applications must be submitted electronically through NIH ASSIST, institutional system-to-system platforms, or Grants.gov Workspace. Required documents include a Milestone Plan, a description of the future clinical trial (distinct from any pilot study), and a detailed research strategy addressing both planning activities and trial goals. The application must adhere to all guidelines in the NIH “How to Apply” guide, including requirements around human subjects research, IRB approvals, and data management plans. The program uses a rolling due date system with multiple annual cycles. Applications are due February 25, June 25, and October 25 each year through October 25, 2027. Submissions must be completed by 5:00 PM local time. The review process includes scientific merit review, advisory council consideration, and earliest possible start dates approximately 6–9 months after submission. Peer review criteria include the significance and innovation of the proposed future trial, the rigor and feasibility of the planning activities, and the expertise of the research team. Applications are evaluated for their potential to inform the design of impactful cancer prevention and control trials that can influence public health and clinical practice. For scientific or research questions related to cancer prevention and early detection, applicants may contact Dr. Goli Samimi at [email protected] or 240-276-6582. For queries related to cancer control and population sciences, contact Dr. Stephanie Land at [email protected] or 240-276-6946. Financial questions may be directed to Crystal Wolfrey at [email protected] or 240-276-6277. The full announcement and additional materials are available on the NIH website under PAR-25-104.

Include sufficient preliminary data and describe trial rigor; ensure your milestone plan is realistic and measurable; avoid non-responsive formats and ensure all required documents are uploaded properly.