Development of a Pediatric Clinical Trials Consortium to Increase Research Exposure for Children and Adolescents in Louisiana

Lsu Pennington Biomedical Research Ctr, Baton Rouge LA

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY / ABSTRACT Establishing improved access to pediatric clinical trials is critical given the poor state of health and intractable health disparities that face children in Louisiana, particularly in relation to the four focus areas of the Environmental influences on Child Health Outcomes (ECHO): obesity, neurodevelopment, asthma, and birth outcomes. Given our current understanding of the developmental origins of health and disease, increasing pediatric clinical trials targeting early disease and risk factors for later health outcomes, particularly in populations including ethnic minorities where risk factors are elevated, is critical. This proposal plans to establish a pediatric clinical trials site in Louisiana in response to RFA-OD-16-001, Clinical Sites for the IDeA States Pediatric Clinical Trials Network (UG1) to address this critical need for pediatric clinical trials in this State. The purpose of this proposal is to establish an innovative consortium based at Pennington Biomedical Research Center (PBRC) in Baton Rouge, LA in collaboration with Tulane University in New Orleans, LA. The overall goal is to leverage the existing clinical research expertise of PBRC in obesity and maternal-fetal health with the clinical expertise and experience of Tulane University School of Medicine in asthma, neurodevelopment, and birth outcomes to establish a uniquely skilled collaborative group able to engage, implement, and translate a range of pediatric clinical trials. Moreover, working with the established infrastructure and modeling the processes of inter-institutional collaboration created by the Louisiana Clinical and Translational Science Center (LA CaTS) (PI: William Cefalu; NIH 1 U54 GM104940) will allow for further dissemination and conduct of clinical trials across the State. The investigators will be supported by a research coordinator at each site and a data manager at PBRC. Regularly scheduled meetings between the investigative teams as well as with the IDeA States Pediatric Clinical Trials Network (ISPCTN) will be held to discuss developments, progress, and future directions. Year 1 will be focused on administrative planning including identifying targeted recruitment sites, establishing appropriate letters of agreement, and streamlining IRB workflow. Years 2 through 4 will be focused on conducting multiple clinical trials as deemed appropriate by the ISPCTN. By expanding the research infrastructure in Louisiana, creating uniform protocols, and integrating with other sites across the United States, we expect the PBRC/Tulane consortium to rapidly participate in clinical trials, initiated locally as well as within the network, bringing new discoveries to children in Louisiana while simultaneously addressing persistent health disparities.