NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)

US Dept. of Health & Human Services: National Institutes of Health (NIH)

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Next deadline: Oct 21, 2024

Later deadlines: Nov 13, 2024, Jun 23, 2025, Jul 17, 2025, Feb 23, 2026, Mar 17, 2026, Oct 20, 2026, Nov 13, 2026

Grant amount: Unspecified amount

Fields of work: Food Safety Drug Safety Integrative & Alternative Health

Applicant type: Nonprofit, Government Entity, Indigenous Group, For-Profit Business

Funding uses: Research

Location of project: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico Show all

Location of residency: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico Show all

Overview:

NOTE: All applications are due by 5:00 PM local time of applicant organization. 

Standard Grants and Resubmission applications are due: 

  • March 4, 2024
  • October 21, 2024
  • June 23, 2025
  • February 23, 2026
  • October 20, 2026

AIDS-related submissions are due:

  • March 13, 2024
  • November 13, 2024
  • July 17, 2025
  • March 17, 2026
  • November 13, 2026

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-phase clinical trials of natural products(i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. All applications submitted under this NOFO must be supported by sufficient preliminary data demonstrating bioavailability (if applicable) and documentation that the natural product produces a reproducible and measurable impact on target engagement (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure target engagement in the patient population of interest or when there is a fundamental understanding of the products mechanism of action will this preliminary data requirement be waived. '

Applications submitted to this NOFO should propose a mid-phase clinical trial to do the following: determine the optimal dose or formulation of a given natural product for use in a future multi-site efficacy trial; or determine which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy trial. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. 

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US Dept. of Health & Human Services: National Institutes of Health (NIH)
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This page was last reviewed February 03, 2024 and last updated February 03, 2024