The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is offering a funding opportunity for the establishment of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials focused on mind and body interventions. Applicants are required to develop comprehensive plans that include project management, participant recruitment, and data analysis, while collaborating with a corresponding Data Coordinating Center (DCC) to ensure the trials are scientifically robust and aligned with NCCIH's research priorities. This initiative aims to explore the efficacy and effectiveness of complementary health approaches, emphasizing the inclusion of diverse populations and the necessity for a detailed plan to enhance diversity in research teams and subjects. Interested applicants must submit their proposals by January 20, 2025, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. For more details, please refer to the full announcement available at https://grants.nih.gov/grants/guide/pa-files/PAR-24-275.html.

PAR-24-275.html

The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), announces a funding opportunity for the Clinical Coordinating Center (CCC) via cooperative agreements (UG3/UH3) to support multi-site investigator-initiated clinical trials on mind and body interventions. This funding aims to explore the efficacy and effectiveness of complementary health approaches, particularly those combining physical and psychological therapeutic inputs. Applications must provide detailed plans including project management, participant recruitment, and data analysis in a collaborative setting with a corresponding Data Coordinating Center (DCC). Key components to address include study design, power analysis, and consideration of diverse perspectives in research. The opportunity emphasizes the inclusion of diverse populations and the necessity of a comprehensive plan (PEDP) for enhancing diversity in research teams and subjects. Interested applicants must adhere to specific registration protocols, budget guidelines, and provide preliminary data to support their proposals. Application deadline is set for January 20, 2025, with proposed projects being evaluated for scientific relevance and priority alignment with NCCIH's objectives for advancing health through evidence-based complementary strategies.

https://grants.nih.gov/grants/guide/pa-files/PAR-24-275.html

This notice of funding opportunity (NOFO) encourages 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 (CCC) should develop and implement the proposed fully powered multi-site clinical trial (Phase III and beyond). The objective of a CCC application is to present the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. CCC applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. CCC 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 (DCC) application (U24), submitted under PAR-24-087 proposing a data analysis and data management plan for the clinical project is required. Both a CCC application and a corresponding DCC application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of NCCIH, applicants are encouraged to consult the NCCIH website: (https://nccih.nih.gov/about/plans). Applicants are encouraged to contact the appropriate Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.

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 Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required)

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