Collaborative Pediatric Critical Care Research Network - Clinical Site

项目总结/摘要-杜克大学 我们的首要目标是加入新组织和扩大的协作儿科重症监护 研究网络（CPCCRN）作为一个新的网站，是为了提高网络的科学广度和影响力， 最大限度地发挥其公共卫生影响，并改善重症儿童的预后。我们的网站，由杜克 北卡罗来纳州达勒姆的大学（主要地点）和南卡罗来纳州的医科大学（MUSC; 南卡罗来纳州查尔斯顿的一个辅助站点），为每1000名重症儿童提供全面护理。 年，两国。我们的研究中心提供89张儿科重症监护病床，我们将共同努力， 确保南卡罗来纳州的所有重症儿童都能获得最先进的临床试验和研究 由CPCCRN进行的研究。我们致力于通过以下措施改善重症儿童的预后： 多中心协作临床研究。在过去的3年里，我们已经招募了超过400名重症儿童， 在杜克进行的15项临床研究，由领先的多中心临床研究网络协调。我们 基于网站的研究团队是由一个全面的部门和医学院广泛的临床支持 研究基础设施，提供全面的服务，行政，财务，监管和科学支持。我们 拟任研究协调员Harward女士拥有5年以上的多中心临床试验经验 在重症儿童中。我们提议的首席研究员，霍尼克博士，将他的职业生涯奉献给了 通过开发安全有效的药物，改善重症儿童的预后， 干预措施。Hornik博士是儿科重症监护医学和心脏病学委员会认证， 在生物统计学和制药科学方面的培训，以及在重症儿童中招收重症儿童的记录， 临床试验和指导早期职业研究者。作为一名教师，在两个部门的 儿科和杜克临床研究所（DCRI），世界上最大的学术研究 组织，Hornik博士建立了一个研究和领导组合，非常适合提高科学的广度 的CPCCRN。利用我们协调大型多中心儿科临床研究网络的经验， 包括NICHD资助的儿科试验网络，FDA支持的全球儿科临床试验 网络和NCATS试验创新网络，以及通过 定量科学和DCRI药物计量学中心，我们将提供深入的科学专业知识， 为CPCCRN研究者提供临床药理学、真实的- 世界证据生成和监管科学。通过我们的临床覆盖面和科学专业知识，我们将 为CPCCRN的成功做出重大贡献，培养有才华的临床科学家， 完成我们高度创新的临床试验，旨在降低MODS的发病率和死亡率， 重症婴幼儿。

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.