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

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-phase clinical trials of natural products, which have a strong scientific premise to justify further clinical testing. The natural products may include botanicals, dietary supplements, and probiotics, and must have compelling preliminary evidence. The clinical trials should propose to 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. • The opportunity is focused on mid-phase clinical trials of natural products. • The natural products must have a strong scientific premise to justify further clinical testing. • The clinical trials should be hypothesis-based, milestone-driven, and directly related to the research priorities and mission of NCCIH. • The opportunity will not support single-site or multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer.