This Funding Opportunity Announcement (FOA) invites cooperative agreement applications for investigator-initiated mid-phase clinical trials of natural products. All applications submitted under this FOA must be supported by sufficient preliminary data of bioavailability and documentation that the natural product produces a replicable and measurable impact on a biological signature (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure a biological signature in the patient population of interest or when there is a fundamental understanding of the product’s mechanism of action will this preliminary data requirement be waived.
Applications submitted to this FOA should propose a mid-phase clinical trial to do the following: determine the optimal dose or formulation of a given natural product for use in a future multi-site clinical trial; or determine which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy study. Clinical trials submitted under this FOA are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This FOA 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.
Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA.
Application Due Date(s):
New Applications: July 20,2020; February 01, 2021; October 01, 2021; June 01, 2022; February 01, 2023, June 05, 2023
Resubmission and Revision: July 20, 2020; February 17, 2021; October 15, 2021; June 15, 2022; February 15, 2023