NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
National Institutes of Health · Research and Training in Complementary and Integrative Health (93.213)
Posted 2 Dec 2024 · 44 days left
Summary
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…
Excerpt from the donor's page. The full text, annexes and forms are on the original call.
Eligibility and conditions
Show the eligibility text from the source
Applicant types: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Private institutions of higher education; Small businesses; Others (see text field entitled "Additional Information on Eligibility" for clarification); Public housing authorities/Indian housing authorities; Independent school districts; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Native American tribal organizations (other than Federally recognized tribal governments); City or township governments; Native American tribal governments (Federally recognized); State governments; For profit organizations other than small businesses; Public and State controlled institutions of higher education; Special district governments; County governments
Other Eligible Applicants include the following:
Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.