Trialect

Active

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

National Institutes of Health

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, probiotics, and products marketed as dietary supplements), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Under this NOFO, 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 NOFO 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 specified target measure. 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 target engagement(s) when used by humans and assess whether there is an association between the degree of the impact on the target engagement and clinical outcomes in a participant population. Applications are encouraged to design R33 studies to determine how to optimize the impact of the natural product on the target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same target engagement measure; or study the impact of the natural product in a population that is more responsive. Clinical trials submitted under this NOFO 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 NOFO 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 NOFO.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

Companion FOAs

PAR-24-115 , R01 Research Project
PAR-24-116 , R33 Exploratory/Developmental Grants Phase II
PAR-24-123 , UG3 / UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
PAR-24-125 , U24 Resource-Related Research Project (Cooperative Agreements)

Deadlines:

Letter of Intent Due Date(s): 30 days prior to the application due date
Application Due Date(s): March 4, 2024; Oct 21, 2024; June 23, 2025; Feb 23, 2026; Oct 20, 2026
AIDS Application Due Date(s): March 13, 2024; Nov 13, 2024; July 17, 2025; March 17, 2025; Nov 13, 2026

PAR-24-124 Expiration Date November 14, 2026

Specialties

Medical

Medical - Clinical Science

Medical - Basic Science

Medical - Translational

Eligibility Requirements

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

View Funding Opportunity

Grant

Final Deadline:

Oct 21, 2024

LOI Deadline: 30 days prior to the application due date Application Due Date(s):March 4, 2024; Oct 21, 2024; June 23, 2025; Feb 23, 2026; Oct 20, 2026