Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required)

The National Institutes of Health (NIH), specifically through the National Center for Complementary and Integrative Health (NCCIH), is inviting applications for funding under the U24 Resource-Related Research Projects Cooperative Agreement. This funding opportunity, identified as PAR-24-313, supports a Data Coordinating Center (DCC) that will work alongside a Clinical Coordinating Center (CCC) in a multi-site clinical trial to assess the efficacy or effectiveness of natural products. Both the DCC and CCC applications must be submitted simultaneously for consideration. The DCC will provide essential project coordination, including data management, biostatistical support, and administrative oversight, to ensure trial integrity across multiple sites. Research projects supported under this NOFO must align with NCCIH’s mission and research priorities, which can be referenced on the NCCIH website. The goal of the DCC is to maintain data integrity, support appropriate study design, and manage participant recruitment and retention, while also providing masking of intervention assignments, randomization, data analysis, and reporting to the Data and Safety Monitoring Board (DSMB). The DCC must operate independently from the CCC to provide objective oversight and coordination across trial sites. Applications should also include strategies for monitoring adverse events and ensuring data accuracy for meaningful subgroup analyses. Multi-site trials are expected to enroll participants from at least two different locations, though additional sites are recommended to enhance the generalizability and statistical power of the study findings. The U24 funding mechanism will support this project through a structured, milestone-driven approach. In the first year, corresponding with the UG3 planning phase of the CCC, the DCC will establish the foundational elements of the trial, such as developing data quality assurance plans, case report forms, and trial databases. This phase will also involve coordinating recruitment, finalizing protocols, and ensuring Institutional Review Board (IRB) and DSMB approvals. The DCC must also outline a comprehensive project management plan, including timelines, feasibility assessments, and contingency strategies to support efficient project completion. Upon successful completion of the UG3 phase milestones, the DCC will transition to support the full implementation phase (UH3) of the CCC, with continued funding contingent on the achievement of pre-defined milestones and ongoing administrative reviews. Milestones are a central requirement in this NOFO, serving as performance benchmarks for project advancement. Applicants are required to propose specific, performance-based milestones that demonstrate readiness to proceed to trial implementation. Projects will be evaluated for continuation based on the DCC’s ability to meet these milestones, maintain data integrity, and achieve participant accrual targets within budget and time constraints. Milestones will be closely monitored by NCCIH staff in collaboration with the DCC, with an option for periodic external peer review to assess progress and address potential delays. Failure to meet projected milestones may result in phased termination of the award. This NOFO also emphasizes the importance of enhancing diversity and inclusivity in research through the submission of a Plan for Enhancing Diverse Perspectives (PEDP). This plan should outline strategies to integrate diverse perspectives, considering various backgrounds in scientific expertise, study populations, and research locations. The PEDP will be evaluated for its contributions to the scientific merit of the application. Applications missing a PEDP will be considered incomplete and will not proceed to review. Eligible applicants include a wide range of U.S.-based institutions, such as public and private higher education institutions, nonprofits, for-profit organizations, government entities, and federally recognized tribal governments. Non-U.S. entities and non-U.S. components of domestic organizations are not eligible to apply. Applicants must complete all required registrations (e.g., SAM, eRA Commons, and Grants.gov) before submission. Applications are due by 5:00 PM local time on specified deadlines, with no exceptions for late submissions. A letter of intent, while not mandatory, is recommended 30 days before the application deadline to aid NCCIH in planning the review workload.