Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional)

The Cancer Prevention and Control Clinical Trials Planning Grant Program (U34) by the National Cancer Institute (NCI) under the National Institutes of Health (NIH) is designed to support the planning and development of clinical trials across the cancer prevention and control spectrum. This program, reissuing PAR-22-174, assists in addressing gaps in preliminary data that are essential for designing effective multi-center Phase II or later trials. The funding is targeted at reducing common barriers in clinical trial planning, such as patient recruitment and protocol development, to minimize subsequent delays and costs that might impede the full-scale study’s success. Funding is intended for investigators with existing efficacy data who need additional support to address critical gaps in trial logistics, design, and feasibility. The program focuses on trials addressing cancer prevention, early detection, and healthcare delivery, along with the management of symptoms, supportive care, and outcomes for cancer survivors. Examples of supported preparatory activities include refining study populations, standardizing interventions across sites, developing recruitment strategies, and piloting methods for data collection. Importantly, applications may propose pilot or feasibility studies if necessary to establish a basis for larger trials. The maximum budget is $225,000 per year, with total funding of up to $450,000 over three years. Applications involving feasibility clinical trials may extend to $600,000 over the same period. Eligible applicants include a range of higher education institutions, nonprofits, for-profit organizations, state and local governments, tribal organizations, and foreign institutions. All applicants must complete registrations in SAM.gov, Grants.gov, eRA Commons, and other required systems to be eligible. Submissions require a Plan for Enhancing Diverse Perspectives (PEDP), outlining actionable strategies to foster inclusivity, as this is a mandatory component evaluated during the review. Applications without a PEDP will be administratively withdrawn. Applications will be assessed on three main criteria: (1) the importance of the research, including the significance and innovation of the study; (2) rigor and feasibility, evaluating the study design, statistical methodology, and recruitment strategy; and (3) the expertise and resources of the investigators and institution. Specific factors include the clarity of milestones, recruitment feasibility, adequacy of proposed sample sizes, and plans for stakeholder engagement. Proposals must also include detailed plans for data management, a study timeline, and an attachment outlining the future clinical trial. The application deadlines are biannual, with the earliest due date on February 25, 2025, and the program accepting applications through October 2027. Key contacts include NCI’s Brandy Heckman-Stoddard for prevention-focused trials and Kate Castro for cancer care delivery inquiries. Applications are encouraged to be submitted early to accommodate any necessary corrections, and all funding decisions will be based on scientific merit, alignment with program priorities, and the availability of NIH funds.