Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required) (352183)

US Dept. of Health & Human Services: National Institutes of Health (NIH)

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Next deadline: Jun 21, 2024

Later deadlines: Jul 15, 2024, Feb 20, 2025, Mar 10, 2025, Jun 23, 2025, Jul 17, 2025, Feb 23, 2026, Mar 17, 2026, Jun 22, 2026, Jul 14, 2026

Grant amount: Unspecified amount

Fields of work: Integrative & Alternative Health Food Safety Drug Safety

Applicant type: Nonprofit, Government Entity, Indigenous Group, For-Profit Business

Funding uses: Research, Training / Capacity Building

Location of project: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico Show all

Location of residency: United States, American Samoa, Guam, Northern Mariana Islands, Puerto Rico Show all

Overview:

NOTE: The following deadlines apply to standard grant applications (due by 5:00 pm local time of applicant organization. 

  • March 4, 2024
  • June 21, 2024
  • February 20, 2025
  • June 23, 2025
  • February 23, 2026
  • June 22, 2026

The following deadlines apply to AIDS-related grant applications (due by 5:00 pm local time of applicant organization).

  • March 13, 2024
  • July 15, 2024
  • March 10, 2025
  • July 17, 2025
  • March 17, 2026
  • July 14, 2026

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-20-219, 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. 

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US Dept. of Health & Human Services: National Institutes of Health (NIH)
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This page was last reviewed February 05, 2024 and last updated February 05, 2024