Collaborative Pediatric Critical Care Research Network - Clinical Site

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PROJECT SUMMARY/ABSTRACT - Duke University Our overarching objective in joining the newly organized and expanded Collaborative Pediatric Critical Care Research Network (CPCCRN) as a new site is to enhance the scientific breadth and reach of the network to maximize its public health impact and improve outcomes for critically ill children. Our site, consisting of Duke University (primary site) in Durham, North Carolina, and the Medical University of South Carolina (MUSC; ancillary site) in Charleston, South Carolina, provides comprehensive care to > 4000 critically ill children per year in both states. Our sites provide access to 89 combined pediatric intensive care bed, and together, we will ensure that all critically ill children in the Carolinas have access to cutting edge clinical trials and research studies performed by the CPCCRN. We are committed to improving outcomes of critically ill children through collaborative multicenter clinical research. Over the past 3 years, we have enrolled >400 critically ill children in 15 clinical studies conducted at Duke and coordinated by leading multicenter clinical research networks. Our site based research team is supported by a comprehensive departmental and school of medicine wide clinical research infrastructure that provides full service administrative, financial, regulatory, and scientific support. Our proposed research coordinator, Mrs Harward, has >5 years of experience conducting multicenter clinical trials in critically ill children. Our proposed principal investigator, Dr. Hornik, has dedicated his professional life to improving outcomes of critically ill children through the development of safe and effective drugs and interventions. Dr. Hornik is board certified in pediatric critical care medicine and cardiology, has advanced training in biostatistics and pharmaceutical sciences, and a track record of enrolling critically ill children in clinical trials and mentoring early-career investigators. As a faculty member in both the Department of Pediatrics and the Duke Clinical Research Institute (DCRI), the world’s largest academic research organization, Dr. Hornik built a research and leadership portfolio ideally suited to enhance the scientific breadth of the CPCCRN. Leveraging our experience coordinating large multicenter pediatric clinical research networks, including the NICHD funded Pediatric Trials Network, the FDA supported Global Pediatric Clinical Trials Network, and the NCATS Trial Innovations Network, and the resources accessible through the Division of Quantitative Sciences and the DCRI Pharmacometrics Center, we will provide deep scientific expertise and training and mentoring opportunities for CPCCRN investigators in the areas of clinical pharmacology, real- world evidence generation, and regulatory science. Through our clinical reach and scientific expertise, we will contribute significantly to the success of the CPCCRN, development of talented clinician scientists, and completion of our highly innovative clinical trial aimed at reducing the morbidity and mortality of MODS in critically ill infants and children.