Data Coordinating and Operations Center (DCOC) for the IDeA States Pediatric Clinical Trials Network

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PROJECT SUMMARY/ABSTRACT Each year in Lafayette County, Arkansas, 16 of every 1,000 infants die before their first birthday;1 this infant mortality rate is greater than that of many second-world countries. Thirty-six percent of Arkansas residents live in rural areas, almost one in three children lives in poverty, and all counties are medically underserved.2 Arkansas is an IDeA state and is joined in these disparities by similarly rural states. Infants and children living in rural and medically underserved IDeA states are less likely than those living in urban states to be enrolled in and benefit from clinical research, especially clinical trials.3-5 To address this disparity in pediatric research, the Environmental Influences on Children Health Outcomes (ECHO) initiatives will establish the IDeA States Pediatric Clinical Trials Network (ISPCTN) to increase representation of and access to clinical trials by children in underserved states with disproportionately low NIH funding. Up to 15 clinical sites located in IDeA states will be funded and supported by one Data Coordinating and Operations Center (DCOC). As such, the University of Arkansas for Medical Sciences (UAMS) proposes to create the DCOC. Being an academic medical center with a robust clinical research portfolio and experience with conducting research in rural and underserved areas, the proposed team at UAMS is well positioned to serve as the DCOC. The key personnel work across the four ECHO priority areas and are prepared to help ISPCTN sites do the same. The DCOC will work collaboratively with ISPCTN clinical centers to build capability for and increase access to pediatric clinical research in IDeA states to increase generalizability of trial results. To establish the DCOC, UAMS will:  Specific Aim 1: Establish a coordinating center infrastructure to support trials conducted by the IDeA States Pediatric Clinical Trials Network. The proposed DCOC will create a cost-effective operations and data-coordinating infrastructure to support ISPCTN clinical trials.  Specific Aim 2: Execute the operational tasks and scientific responsibilities of the DCOC as required within the collaborative agreement. The DCOC will support the operations, logistics, data management, and biostatistics needs of the ISPCTN.  Specific Aim 3: Develop and implement relevant professional development programs to establish highly competent pediatric clinical trial teams in IDeA states. The DCOC will leverage existing infrastructure to provide professional development and mentoring. The objective of the DCOC is to support the development and implementation of clinical research within the ISPCTN. The UAMS team will work collaboratively with clinical investigators at the ISPCTN sites, Project Scientists, Program Officials, and other NIGMS and NICHD staff to select or design, implement and oversee clinical trials addressing the ECHO priority areas and the health needs of children living in IDeA states.