Data Coordinating and Operations Center for the ECHO IDeA States Pediatric Clinical Trials Network - Project Summary Many children, particularly those in rural and underserved communities, lack vital access to pediatric clinical trials. This project addresses this disparity by proposing a Data Coordinating and Operations Center (DCOC) for the NIH Environmental influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN), a national leader in this field. The project acknowledges current challenges faced by these communities, including geographical limitations, lack of trusted local information, logistical hurdles, and healthcare providers unfamiliar with conducting clinical trials. The proposed ISPCTN DCOC at the University of Kansas Medical Center (KUMC) in partnership with the University of Nebraska Medical Center (UNMC) aims to bridge this gap by leveraging the complementary expertise of both institutions. The KUMC-UNMC DCOC will actively support clinical trial activity by facilitating development, conduct, and results dissemination of multicenter trials focused on rural and underserved children. Additionally, the DCOC will empower researchers, clinicians, and community stakeholders in IDeA states by providing them with the necessary training and support to build their pediatric clinical research capacity. Finally, the project emphasizes the importance of community engagement. The DCOC will foster collaboration with communities, along with nonprofit and professional societies, to ensure that clinical trials are culturally relevant, rigorously designed, and have a significant impact on child health outcomes. The KUMC-UNMC DCOC will build upon the outstanding foundation of policy and procedures developed in the first two cycles of the network to further increase academic productivity and enhance the identification, development, execution, and results dissemination of high quality pediatric clinical trials in these areas. The DCOC will integrate Quality by Design; continuous quality improvement; real-time goals, objectives, indicators, and targets monitoring; multi-faceted professional development; community research engagement and literacy; and learning collaborative approaches to ISPCTN clinical trial operations and capacity-building. This initiative promises to increase access to clinical trials for a wider range of children, while strengthening pediatric research capabilities in underserved areas. Ultimately, the goal is to deliver high-quality, culturally sensitive clinical trials that generate valuable knowledge and lead to improved health outcomes for children across the United States and beyond.
