The National Institutes of Health (NIH) is offering a funding opportunity for cooperative agreements to establish a Clinical Coordinating Center (CCC) for multi-site, investigator-initiated clinical trials focused on the effects of natural products, such as botanicals and dietary supplements. Applicants are required to develop a comprehensive scientific and operational plan for the clinical trial, including project management, participant recruitment, and performance milestones, while also submitting a companion Data Coordinating Center (DCC) application. This initiative aims to generate robust clinical data to inform integrative health approaches and public health strategies, with applications opening on January 20, 2025, and closing on July 14, 2026. For further details, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-24-312.html.

PAR-24-312.html

The Department of Health and Human Services, through the National Center for Complementary and Integrative Health (NCCIH), is issuing a funding opportunity for cooperative agreements to support multi-site, investigator-initiated clinical trials studying the effects of natural products. This funding mechanism, designated as UG3/UH3, aims to establish a Clinical Coordinating Center (CCC) and requires a companion Data Coordinating Center (DCC) application. The trials should focus on areas such as nutritional regimens and dietary supplements with promising preliminary evidence. 

Eligible applicants include higher education institutions, nonprofits, and government entities, with funding available contingent on appropriations and the quality of applications submitted. Rigor in trial design, participant recruitment, and diverse perspectives are emphasized, as well as adherence to regulatory standards such as those from the FDA. Key dates include an open application date starting January 20, 2025, with an expiration on July 15, 2026. The overall aim is to generate robust clinical data on the efficacy of natural products to inform integrative health approaches and public health strategies.

https://grants.nih.gov/grants/guide/pa-files/PAR-24-312.html

This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for investigator-initiated, multi-site, clinical trials (Phase III and beyond) to study the effects of natural products (i.e. botanicals, probiotics, and products marketed as dietary supplements) in NCCIH designated areas of high research priority. 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. Applicants should describe plans for a Clinical Coordinating Center to develop and implement the proposed multi-site clinical trial. The objective of the Clinical Coordinating Center application is to provide the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. Clinical Coordinating Center applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Clinical Coordinating Center applications submitted under this NOFO will utilize a two-phase, milestone-driven, cooperative agreement (UG3/UH3) funding mechanism. In addition, an accompanying Data Coordinating Center application, submitted under PAR-24-125, proposing a data analysis and data management plan for the clinical project is required. Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center (DCC) application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (https://nccih.nih.gov/about/plans).

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

NIH Grants Information&lt;br/&gt;grantsinfo@nih.gov

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

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