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

This program funds investigator-initiated early phase cancer clinical trials, including Phase 0, I, and II studies of diagnosis and treatment interventions. It is for R01 applications and accepts only clinical trials; phase III trials, observational studies, and studies that do not meet the NIH clinical trial definition are not responsive. Eligible applicants include U.S. and foreign organizations, nonprofits, universities, governments, small businesses, and other listed entity types, and foreign components are allowed. Application budgets are limited to no more than $499,999 in direct costs per year, the project period can be up to 5 years, and no cost sharing is required. There is no stated geographic restriction, but the trials must be relevant to NCI’s Division of Cancer Treatment and Diagnosis and/or the Office of HIV and AIDS Malignancies.

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• Education
• Health
• Research & Discovery
• Patients & People with Health Conditions
• Biomedical & Disease Research

• ✓ City or township governments
• ✓ County governments
• ✓ For-profit organizations other than small businesses
• ✓ Independent school districts
• ✓ Native American tribal governments (Federally recognized)
• ✓ Native American tribal organizations (other than Federally recognized)
• ✓ Nonprofits with 501(c)(3) status (other than higher education)
• ✓ Nonprofits without 501(c)(3) status (other than higher education)
• ✓ Others
• ✓ Private institutions of higher education
• ✓ Public and State controlled institutions of higher education
• ✓ Public housing authorities / Indian housing authorities
• ✓ Small businesses
• ✓ Special district governments
• ✓ State governments