OpportunityTitle: Phased Innovation Award for Exploratory Clinical Trials of Natural Products in NCCIH High Priority Research Topics (R21/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 for up to two years (R21 phase) for milestone-driven bioavailability and pharmacokinetic testing and assessment of the natural products biological signature or mechanism of action. Based on the results of the R21 phase, this may be followed by support of up to 3 years (R33 phase) of support for further clinical studies of the natural product. This FOA is not appropriate for support of randomized clinical trials to test or determine efficacy. Ultimately, this R21/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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