OpportunityTitle: Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R33)
AdditionalInformationOnEligibility: 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); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.  Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Description: The goal of this funding opportunity is to support pilot testing of natural products (i.e., botanicals, dietary supplements, and probiotics), which have sufficient early-stage data to justify further clinical testing of the product. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. The data collected should be used to fill gaps in scientific knowledge and provide the information necessary to develop a competitive full-scale clinical trial.Support will be provided to confirm the link between the impact of the natural product on the biological signature (i.e., mechanism of action) and demonstrate an association between the change in the biological signature and clinical outcomes. This FOA is not appropriate for support of randomized clinical trials to test or determine efficacy. Ultimately, this R33 funding mechanism is intended to speed the translation of emerging basic science findings about natural products into clinical pilot testing to determine whether continued clinical research is warranted.
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