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

The National Center for Complementary and Integrative Health (NCCIH) has announced a new Notice of Funding Opportunity (NOFO) aimed at supporting the scientific study of natural products. This initiative encourages applications for cooperative agreements for clinical trials (Phase III and beyond) which are initiated by investigators across multiple sites.

The scope of the trials includes the study of the effects of various natural products such as botanicals, probiotics, and dietary supplement products. Notably, the NCCIH is particularly interested in nutritional regimens that standardize the amount of naturally occurring nutritional compounds like omega-3 fatty acids, anthocyanidins, or polyphenols. These products should ideally have compelling preliminary evidence to be considered for this funding opportunity.

As part of this initiative, applicants should lay out detailed plans for a Clinical Coordinating Center that will manage and implement the proposed multi-site clinical trial. The goal of this center is to deliver a comprehensive scientific and operational structure for the trial, dealing with project management, participant recruitment and retention strategies, scientific conduct, and the sharing of results.

Funding for projects under this NOFO will be dispensed using a two-phase, milestone-driven, cooperative agreement under the UG3/UH3 funding mechanism. In addition to this, a Data Coordinating Center application under PAR-20-219 must be submitted to propose a suitable data management and analysis plan for the project. This data center application should be submitted simultaneously with your Clinical Coordinating Center application for consideration by the NCCIH.

You can get more information about the mission, strategic vision, and research priorities of NCCIH by visiting their official website.