The National Center for Complementary and Integrative Health (NCCIH), under the National Institutes of Health (NIH), invites applications for funding under the notice of funding opportunity (NOFO) titled "Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required)." This reissued opportunity (PAR-24-276) supports a Data Coordinating Center (DCC) that will operate in tandem with a Clinical Coordinating Center (CCC) under the companion NOFO PAR-24-275. The goal is to support multi-site investigator-initiated clinical trials testing mind and body interventions relevant to NCCIH’s mission, particularly trials beyond Phase III. A collaborative submission of both a DCC and CCC application is required; each must be scientifically aligned and submitted on the same deadline for review.
The DCC is expected to provide comprehensive administrative, data management, statistical, and project coordination support. This includes contributing to study design, ensuring quality control and data integrity, managing randomization, monitoring adverse events, conducting statistical analyses, and supporting results dissemination. The trials must include at least three geographically distinct recruitment sites (or two with strong justification), and they should strive for inclusivity across demographic lines to meet NIH’s inclusion policies. The DCC must function independently from the CCC to preserve the integrity of data and study processes.
The funding mechanism is a cooperative agreement (U24), and applications may request a project period of up to five years, or up to seven years if well justified. Budgets are not capped but must be justified according to project needs, and any year with direct costs exceeding $500,000 requires prior approval. Milestones are central to funding continuity, with year-two and beyond contingent upon successful completion of year-one deliverables, jointly assessed with the CCC. The DCC and CCC must collaborate closely to synchronize timelines and responsibilities for trial launch, execution, and completion.
Eligibility is broad and includes institutions of higher education, nonprofits, for-profits, government entities, and others. However, foreign organizations are not eligible to apply, though foreign components may participate as collaborators. Registrations with SAM, eRA Commons, and Grants.gov are required before submission. Applicants must include a project management plan, milestone plan, and a clinical trial experience table. The DCC application must also demonstrate capacity for data sharing and include risk management strategies for trial implementation.
Applications are due by 5:00 PM local time on specified deadlines, including February 20, 2025, and June 20, 2025, with future due dates extending into 2026. Reviews will include both scientific merit and feasibility, with milestones and project coordination strategies being key evaluation factors. Applicants are encouraged to contact the NCCIH well in advance (12 weeks) of submission to discuss project relevance and receive guidance.
Evaluation will be based on criteria such as significance, innovation, approach, investigator capability, and environment. Applications must show potential to significantly impact the field, address unmet needs, and be executed with efficiency and rigor. The award also entails ongoing collaboration with NIH staff and the establishment of a Trial Management Committee and independent Data and Safety Monitoring Board (DSMB) for oversight. All aspects of human subject protections, data management, and clinical trial registration and reporting are strictly enforced under NIH policies.
