FOA-NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required); July 20, 2020

 

Agency

National Institutes of Health

 

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.

 

Activity Code:

R61/R33 Exploratory/Developmental Phased Award

 

Announcement Number:

PAR-20-218

 

Closing Date:

July 20,2020; February 01, 2021; October 01, 2021; June 01, 2022; February 01, 2023

 

Companion Opportunities:

PAR-20-215 - Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required)

PAR-20-216 - NCCIH Natural Product Phase II Clinical Trial Cooperative Agreement (U01 Clinical Trial Required)

PAR-20-217 - NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)

PAR-20-219 - Natural Product, Multi-Site, Clinical Trial, Data Coordinating Center (Collaborative U24 - Clinical Trial Required)

 

Link to Full Announcement

https://grants.nih.gov/grants/guide/pa-files/PAR-20-218.html