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

Background
The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), is issuing this Notice of Funding Opportunity (NOFO) to support research projects that implement early phase (Phase 0, I, and II) investigator-initiated clinical trials. These trials should focus on cancer-targeted diagnostic and therapeutic interventions relevant to the missions of the NCI's Division of Cancer Treatment and Diagnosis (DCTD) and the Office of HIV and AIDS Malignancies (OHAM). The goal is to advance knowledge in cancer treatment and diagnosis through innovative clinical research.

Grant Details
The proposed project must involve at least one clinical trial related to the scientific interests of one or more of the following research programs: Cancer Therapy Evaluation Program, Cancer Imaging Program, Cancer Diagnosis Program, Radiation Research Program, Complementary and Alternative Medicine Program, and/or the HIV and AIDS Malignancies Research Programs. The NOFO supports various types of early phase clinical trials including single-site, multi-site, mechanistic, feasibility, pragmatic, ancillary, pharmacodynamic, biomarker-driven, co-clinical trials, and those related to HIV/AIDS. Applications must meet the NIH definition of a clinical trial and provide specific clinical trial information as outlined in this NOFO. Phase III clinical trials are not accepted under this NOFO.

Eligibility Requirements
Eligible applicants include higher education institutions (public/state controlled institutions, private institutions), nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), local/state governments, tribal governments, federal agencies, foreign organizations, and other entities such as independent school districts or public housing authorities. Individuals from diverse backgrounds are encouraged to apply.

Period of Performance
The maximum project period for grants awarded under this NOFO is five years.

Grant Value
Application budgets are limited to no more than $499,999 in direct costs per year. The total value of grants will depend on NIH appropriations and the number of meritorious applications received.