NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)

Background
The National Center for Complementary and Integrative Health (NCCIH) is committed to the rigorous investigation of promising complementary and integrative health approaches with nutritional therapeutic inputs (often called natural products). The NCCIH supports investigators working on the continuum of the research framework, from basic science and demonstrating reproducible impact on a target engagement measure, through high impact efficacy trials. The NCCIH has an oversight process to provide stewardship and maintain excellence, integrity, and rigor in supported clinical studies.

Grant Details
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. Trials must be designed so that results will provide information of high scientific utility and will support decisions about further development or testing of the natural product.

The NOFO will provide up to 3 years support for studies to replicate the impact of the natural product on target engagement when used by humans, assess whether there is an association between the degree of the impact on target engagement and functional or clinical outcomes in a patient population, and determine how to optimize the impact of the natural product on target engagement by examining different doses or formulations. 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.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits with 501(c)(3) IRS status, for-profit organizations, state governments, county governments, city or township governments, special district governments, Indian/Native American Tribal Governments (Federally Recognized), U.S. Territory or Possession entities, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), faith-based or community-based organizations. Foreign organizations are not eligible to apply.

Period of Performance
The project period may not exceed 3 years.

Grant Value
The budget should reflect the actual needs of the proposed project but may not exceed a total of $1,050,000 in direct costs over the entire duration of the award.