Establishing improved access to pediatric clinical trials is critical given the poor state of health and intractablehealth disparities that face children in Louisiana, particularly in relation to the four focus areas of theEnvironmental influences on Child Health Outcomes (ECHO): obesity, neurodevelopment, asthma, and birthoutcomes. Given our current understanding of the developmental origins of health and disease, increasingpediatric clinical trials targeting early disease and risk factors for later health outcomes, particularly inpopulations including ethnic minorities where risk factors are elevated, is critical. This proposal plans toestablish a pediatric clinical trials site in Louisiana in response to RFA-OD-16-001, Clinical Sites for the IDeAStates Pediatric Clinical Trials Network (UG1) to address this critical need for pediatric clinical trials in thisState. The purpose of this proposal is to establish an innovative consortium based at Pennington BiomedicalResearch Center (PBRC) in Baton Rouge, LA in collaboration with Tulane University in New Orleans, LA. Theoverall goal is to leverage the existing clinical research expertise of PBRC in obesity and maternal-fetal healthwith 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 establishedinfrastructure and modeling the processes of inter-institutional collaboration created by the Louisiana Clinicaland Translational Science Center (LA CaTS) (PI: William Cefalu; NIH 1 U54 GM104940) will allow for furtherdissemination and conduct of clinical trials across the State. The investigators will be supported by a researchcoordinator at each site and a data manager at PBRC. Regularly scheduled meetings between theinvestigative teams as well as with the IDeA States Pediatric Clinical Trials Network (ISPCTN) will be held todiscuss developments, progress, and future directions. Year 1 will be focused on administrative planningincluding identifying targeted recruitment sites, establishing appropriate letters of agreement, and streamliningIRB workflow. Years 2 through 4 will be focused on conducting multiple clinical trials as deemed appropriateby the ISPCTN. By expanding the research infrastructure in Louisiana, creating uniform protocols, andintegrating with other sites across the United States, we expect the PBRC/Tulane consortium to rapidlyparticipate in clinical trials, initiated locally as well as within the network, bringing new discoveries to children inLouisiana while simultaneously addressing persistent health disparities.
Increasing clinical trials in children especially targeting early disease and risk factors related to laterhealth outcomes as adults is critical for public health; particularly in populations including ethnicminorities where risk factors are elevated. Louisiana consistently ranks near the bottom in terms ofoverall health metrics and has some of the highest rates of obesity; diabetes; and cardiovasculardisease in the country. This proposal will create a consortium based at Pennington BiomedicalResearch Center (PBRC) in Baton Rouge; LA in collaboration with Tulane University in New Orleans;LA superimposing on the current infrastructure locally as well as tapping into the Louisiana Clinicaland Translational Science Center to directly address the need to increase access to state-of-the-artclinical research for underrepresented populations; to enhance pediatric clinical trial capacity; and toimplement well-designed clinical trials in pediatric populations in Louisiana.
| 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 |
