Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required)
This grant funds a Data Coordinating Center for multi-site clinical trials investigating mind-body interventions, requiring coordination and support for Phase III trials and beyond.
Funder: National Institutes of Health
Due Dates: June 20, 2025 | July 14, 2025 (AIDS) | February 20, 2026 | March 17, 2026 (AIDS) | June 22, 2026 | July 14, 2026 (AIDS)
Funding Amounts: No budget cap; budgets must reflect actual project needs. Project period up to 5 years (up to 7 years with strong justification).
Summary: Supports a Data Coordinating Center to provide project coordination, data management, and biostatistical support for multi-site clinical trials of mind and body interventions (Phase III and beyond) in collaboration with a Clinical Coordinating Center.
Key Information: A companion Clinical Coordinating Center (CCC) application must be submitted simultaneously; a Plan for Enhancing Diverse Perspectives (PEDP) is required.
Description
This opportunity funds a Data Coordinating Center (DCC) to support multi-site, investigator-initiated clinical trials of mind and body interventions, such as those for chronic pain, depression, or anxiety. The DCC will work in close collaboration with a Clinical Coordinating Center (CCC) to provide overall project coordination, administrative support, data management, and biostatistical expertise for Phase III and later-stage trials. The DCC must be independent from the CCC and is responsible for ensuring the integrity of data collection, intervention delivery, and study blinding across multiple sites.
The DCC will contribute to study design, adverse event monitoring, randomization, interim data reporting, statistical analyses, and dissemination of results. The program is milestone-driven and performance-based, with continued funding contingent on meeting agreed-upon milestones.
