Notice of Intent to Publish a Notice of Funding Opportunity for Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required)

Key Dates

• June 14, 2021 - Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required). See NOFO PAR-21-243.    

National Center for Complementary and Integrative Health (NCCIH)

The National Center for Complementary and Integrative Health (NCCIH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for a Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required). 

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.   

The NOFO is expected to be published in December 2023 with an expected application due date in Winter 2024.  

This NOFO will utilize the UG3/UH3 activity code. Details of the planned NOFO are provided below.

This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for investigator-initiated multi-site clinical trials (e.g., efficacy, effectiveness, or pragmatic trials) to study the effects of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions), and/or multicomponent interventions that include physical, psychological, and/or nutritional approaches in NCCIH designated areas of high research priority. Clinical Coordinating Centers should develop and implement the proposed fully powered multi-site clinical trial (Phase III and beyond). The objective of a Clinical Coordinating Center application is to present 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 (U24) 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). 

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Elizabeth Ginexi, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-827-0160
Email: [email protected]