Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required)
Funding for multi-site clinical trials studying mind and body interventions in NCCIH priority areas; applicants require CCC and DCC submissions.
Funder: National Institutes of Health
Due Dates: May 21, 2025 (Letter of Intent) | June 20, 2025 (Full Application) | July 14, 2025 (AIDS) | Feb 20, 2026 | June 22, 2026 | July 14, 2026 (AIDS)
Funding Amounts: No budget cap; budgets must reflect actual project needs. UG3 phase: up to 1 year; UH3 phase: typically 4 years (up to 6 years with strong justification).
Summary: Supports multi-site clinical trials of mind and body interventions in NCCIH priority areas; requires simultaneous submission of both a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC) application.
Key Information: Both CCC and DCC applications must be submitted together; only multi-site trials (≥3 sites, or 2 with strong justification) are eligible; non-U.S. organizations are not eligible to apply.
Description
This opportunity funds Clinical Coordinating Centers (CCC) to lead fully powered, multi-site clinical trials (Phase III and beyond) investigating the efficacy, effectiveness, or pragmatic impact of complementary and integrative health approaches—specifically mind and body interventions—in areas of high research priority for the National Center for Complementary and Integrative Health (NCCIH). The CCC is responsible for developing and implementing the clinical trial, including scientific rationale, operational planning, project management, participant recruitment and retention, performance milestones, scientific conduct, and dissemination of results.
A companion Data Coordinating Center (DCC) application (U24 mechanism) is required and must be submitted simultaneously. The DCC will provide independent data management, analysis, and biostatistical support. Both CCC and DCC must be independent (no overlapping personnel).
The funding mechanism is a two-phase, milestone-driven cooperative agreement (UG3/UH3): a start-up phase (UG3, up to 1 year) and a full trial implementation phase (UH3, typically 4 years, up to 6 years with justification).
