National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)

The National Cancer Institute (NCI) is offering funding for investigator-initiated early-phase clinical trials (Phase 0, I, and II) that target cancer diagnostics and treatments. This funding opportunity aims to support research that aligns with the NCI’s Division of Cancer Treatment and Diagnosis (DCTD) and the Office of HIV and AIDS Malignancies (OHAM). The trials should address areas such as cancer therapy evaluation, cancer imaging, diagnostics, radiation research, complementary and alternative medicine, or HIV/AIDS-related cancers. Proposals must focus on at least one clinical trial, but may include additional non-clinical trial research aims. Importantly, this opportunity does not support Phase III trials. Projects should aim to improve cancer diagnosis and treatment, covering diverse interventions including novel anticancer drugs, imaging technologies, radiotherapy approaches, and alternative medicine applications. The trials can explore topics such as drug dosing, pharmacodynamics, new applications of approved agents, and biomarker-driven interventions. Applicants may also propose integrative medicine research, such as the use of dietary or herbal supplements in cancer therapy. The ultimate goal is to generate impactful clinical findings that can advance understanding of therapeutic mechanisms, treatment resistance, or diagnostic strategies. Funding for these early-phase clinical trials allows for single-site, multi-site, mechanistic, feasibility, pragmatic, ancillary, pharmacodynamic, biomarker-driven, or co-clinical trial designs. The scope of eligible trials includes single-site studies involving a single clinical location, as well as multi-site trials that span different demographic or geographic locations. Applicants may also submit proposals for co-clinical trials, which include human and corresponding animal model studies, to explore cancer genetics and therapeutic responses. Proposed studies must meet NIH's clinical trial criteria and must follow NIH guidelines for Good Clinical Practice. Applicants can request up to $499,999 in direct costs per year for a maximum project duration of five years. Higher education institutions, nonprofits, for-profit organizations, government agencies, and foreign organizations are eligible to apply. Eligible organizations must maintain active registrations with SAM, NATO Commercial and Government Entity (NCAGE), eRA Commons, and Grants.gov before applying. Each applicant must submit their proposal electronically and comply with the detailed instructions in the NIH Application Guide. Applications that do not adhere to submission guidelines or NIH criteria may be rejected without review. The application process includes submitting specific components like a detailed Research Plan, Data Management and Sharing Plan, and a study timeline. Applications must describe recruitment and retention strategies for diverse study populations and include a monitoring plan for data and safety. For trials requiring investigational drug or device exemptions, applicants should consult FDA guidelines. NIH will prioritize proposals that demonstrate strong scientific rationale, methodological rigor, and feasibility within the project period, especially for new investigators establishing trial management capabilities. Applications are due by 5:00 PM local time on standard NIH due dates, beginning February 5, 2025, and continuing through January 5, 2027. Applications will undergo a two-tier review process assessing scientific and technical merit, with award decisions based on peer review scores, relevance to program goals, and funding availability. Recipients must comply with NIH’s Data Management and Sharing policies and must register trials in ClinicalTrials.gov. Successful applicants will receive a Notice of Award from NCI with terms and conditions, including requirements for data and safety monitoring and regulatory compliance. For guidance and questions, applicants may contact NCI representatives in their specific research areas (e.g., therapeutic studies, imaging, radiation research, complementary medicine, HIV/AIDS studies) or refer to the NIH Grants Policy Statement for details on federal and NIH grant terms.