NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)

Organization
NIH
Type
NIH
Application Due Date
06-05-2023
Number
PAR-20-218
Comments
LOI due 30 days before application due date
Brief Description

This Funding Opportunity Announcement (FOA) 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. 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.

This FOA will provide up to three years (R61 phase) of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural product’s effect (i.e., measure of mechanism of action) when used by humans on a biological signature(s). If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on the biological signature(s) when used by humans and assess whether there is an association between the degree of the impact on the biological signature and functional or clinical outcomes in a patient population. Applications are encouraged to design R33 studies to determine how to optimize the impact of the natural product on the biological signature by optimizing the delivery of the natural product by examining different doses or formulation. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same biological signature; or study the impact of the natural product in a target population that is more responsive. 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 R61/R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. This FOA will not support efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer. A maximum of 5 years will be supported by the two phases of the R61/R33 award.

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
Resubmission Applications: July 20, 2020; February 17, 2021; October 15, 2021; June 15, 2022; February 15, 2023