Each year in Lafayette County, Arkansas, 16 of every 1,000 infants die before their first birthday;1 this infantmortality rate is greater than that of many second-world countries. Thirty-six percent of Arkansas residents livein rural areas, almost one in three children lives in poverty, and all counties are medically underserved.2 Arkansasis an IDeA state and is joined in these disparities by similarly rural states. Infants and children living in rural andmedically underserved IDeA states are less likely than those living in urban states to be enrolled in and benefitfrom clinical research, especially clinical trials.3-5 To address this disparity in pediatric research, theEnvironmental Influences on Children Health Outcomes (ECHO) initiatives will establish the IDeA StatesPediatric Clinical Trials Network (ISPCTN) to increase representation of and access to clinical trials by childrenin underserved states with disproportionately low NIH funding. Up to 15 clinical sites located in IDeA states willbe funded and supported by one Data Coordinating and Operations Center (DCOC). As such, the University ofArkansas for Medical Sciences (UAMS) proposes to create the DCOC. Being an academic medical center witha robust clinical research portfolio and experience with conducting research in rural and underserved areas, theproposed team at UAMS is well positioned to serve as the DCOC. The key personnel work across the four ECHOpriority areas and are prepared to help ISPCTN sites do the same. The DCOC will work collaboratively withISPCTN clinical centers to build capability for and increase access to pediatric clinical research in IDeA statesto 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 theISPCTN. The UAMS team will work collaboratively with clinical investigators at the ISPCTN sites, ProjectScientists, Program Officials, and other NIGMS and NICHD staff to select or design, implement and overseeclinical trials addressing the ECHO priority areas and the health needs of children living in IDeA states.
DCOC administrators will work collaboratively with clinical investigators and staff to optimize and implementclinical trials that address the challenging health needs of children living in IDeA states. By expanding the reachof clinical trial recruitment to traditionally under-funded states; researchers and clinicians will receive a betterunderstanding of public health in these areas and in populations that may have been underrepresented in suchtrials traditionally.
| Snowden, Jessica; Darden, Paul; Palumbo, Paul et al. (2018) The institutional development award states pediatric clinical trials network: building research capacity among the rural and medically underserved. Curr Opin Pediatr 30:297-302 |
