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NCCIH Natural Product Mid Phase Clinical Trial Cooperative Agreement (U01 Clinical Trial Required)

National Institutes of Health

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-phase clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), 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. All applications submitted under this NOFO must be supported by sufficient preliminary data demonstrating bioavailability (if applicable) and documentation that the natural product produces a reproducible and measurable impact on target engagement (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure target engagement 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 NOFO 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 efficacy 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 trial. 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 NOFO 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 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 Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.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-24-116 , R33 Exploratory/Developmental Grants Phase II
PAR-24-123 , UG3 / UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
PAR-24-124 , R61 / R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants 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-24-115 Expiration Date November 14, 2026

Specialties

Medical

Medical - Clinical Science

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