The Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required), issued by the National Cancer Institute (NCI), a component of the National Institutes of Health (NIH), supports investigator-initiated clinical trials focused on cancer prevention and control. This opportunity, cataloged as PAR-25-167 and a reissue of PAR-24-072, is specifically aimed at supporting studies that address cancer prevention, early detection, screening, healthcare delivery, survivorship, and quality of life. It does not fund trials related to cancer diagnosis or therapeutic interventions. The program is designed to improve public health and clinical practice through high-impact research.

Applications must propose Phase 0-IV clinical trials that align with the missions of NCI’s Division of Cancer Prevention and/or the Division of Cancer Control and Population Sciences. Eligible studies may include behavioral interventions, implementation science, healthcare delivery improvements, and supportive/palliative care. However, applications focused on oncologic therapies or diagnostic imaging are ineligible and will not be reviewed. The NIH emphasizes adherence to its definition of a clinical trial and encourages early communication with NCI staff to ensure proposal alignment.

The funding is available to a broad range of applicant organizations including higher education institutions, nonprofits, for-profits (including small businesses), state and local governments, public housing authorities, and tribal governments. Foreign entities and components of U.S. organizations are also eligible. There is no limit on the budget for proposed applications, but project budgets must reflect actual needs and should not exceed a five-year project period. While cost sharing is not required, applications requesting $500,000 or more in direct costs must coordinate with NIH staff eight weeks prior to submission.

Applications are accepted on NIH standard due dates, including February 5, June 5, and October 5 of each year through January 8, 2027. Letters of Intent are encouraged 30 days before the submission deadline. All submissions must conform to NIH's electronic application procedures and include detailed plans for data sharing, safety monitoring, and study team structure. Applications undergo rigorous peer review focusing on significance, innovation, rigor, feasibility, and investigator expertise.

For application support and scientific inquiries, applicants may contact Dr. Goli Samimi for prevention and symptom management trials or Dr. Tanya Agurs-Collins for cancer control and population sciences trials. Financial inquiries should be directed to Crystal Wolfrey. Assistance is also available through the eRA Service Desk, Grants.gov, and NIH Grants Info.