Department of Health and Human Services, National Institutes of Health

Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required)

Who can apply

  • Nonprofits without 501(c)(3) status
  • Public and state-controlled colleges
  • Small businesses
  • City or township governments
  • Independent school districts
  • Others (see eligibility details)
  • Nonprofits with 501(c)(3) status
  • Federally recognized tribal governments
  • Tribal organizations
  • For-profit organizations (not small businesses)
  • State governments
  • Special district governments
  • Private colleges and universities
  • Public and tribal housing authorities
  • County governments

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

About this grant

The National Institutes of Health (NIH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose early to definitive clinical trials. Trials testing drugs, devices, biologics, procedures, behavioral, social, economic, health services, or other biomedical or non-pharmacological interventions are of interest to this initiative. The trials should align with the research mission of the participating Institutes, Centers, and Offices (ICOs) of the NIH. The NOFO will utilize the R61/R33 activity code, a bi-phasic, milestone-driven award. The R61 phase provides support for planning activities, and the R33 phase provides support for a clinical trial, with a maximum project period of 7 years. Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and relevant projects. Investigators with expertise in clinical trial planning, design, implementation, intervention development, and/or stakeholder engagement are encouraged to consider applying for the NOFO.

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