Collaborative Pediatric Critical Care Research Network - Clinical Site

儿科重症监护协作研究网络 - 临床网站

• 批准号: 10468849
• 负责人: Christoph Hornik
• 金额: $ 8.31万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-13 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10468849
• 关键词: Admission activity; Analgesics; Area; Beds; Biometry; Cardiology; Child; Childhood; Clinical; Clinical Pharmacology; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Comprehensive Health Care; Contracts; Critical Care; Critical Illness; Critically ill children; Data; Data Coordinating Center; Development; Development Plans; Doctor of Philosophy; Drug Labeling; Electronic Health Record; Enrollment; Ensure; Extramural Activities; Faculty; Funding; Generations; Goals; Good Clinical Practice; Government; Individual; Infant; Intensive Care; Intervention; Joints; Leadership; Life; Medical; Medicine; Mentors; Mentorship; Morbidity - disease rate; Multi-Institutional Clinical Trial; National Center for Advancing Translational Sciences; National Institute of Child Health and Human Development; Network Infrastructure; North Carolina; Nutritional Study; Participant; Pediatric Acute Lung Injury; Pediatric Hospitals; Performance; Pharmaceutical Preparations; Pharmacoepidemiology; Pharmacologic Substance; Principal Investigator; Procedures; Protocols documentation; Public Health; Publications; Recording of previous events; Research; Research Infrastructure; Research Institute; Research Personnel; Research Training; Resources; Science; Scientist; Sepsis; Services; Site; South Carolina; Talents; Training; United States Food and Drug Administration; United States National Institutes of Health; Universities; Work; base; career; career development; clinical research site; early-career faculty; expectation; experience; immunoregulation; improved outcome; innovation; medical schools; meetings; member; mortality; participant enrollment; pediatric department; pharmacometrics; programs; research study; sedative; success

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.

项目摘要/摘要 - 杜克大学 我们加入新组织和扩展的协作小儿重症监护的总体目标 研究网络（CPCCRN）作为一个新站点是为了增强网络的科学广度和范围 最大化其公共卫生影响并改善重症儿童的结果。我们的网站，由公爵组成 北卡罗来纳州达勒姆市的大学（主要地点）和南卡罗来纳州医科大学（MUSC; 辅助站点）位于南卡罗来纳州查尔斯顿，为> 4000个重症儿童提供全面护理 在两个州的一年。我们的网站提供了对89个小儿重症监护床的访问权限，一起，我们将 确保卡罗来纳州的所有重症儿童都可以进入前沿临床试验和研究 CPCCRN进行的研究。我们致力于通过 协作多中心临床研究。在过去的三年中，我们已经注册了> 400个重病的孩子 15个在杜克大学进行的临床研究，并由领先的多中心临床研究网络协调。我们的 基于现场的研究团队得到了全面的部门和医学院广泛的临床支持 提供全面服务管理，财务，监管和科学支持的研究基础设施。我们的 拟议的研究协调员Harward夫人在进行多中心临床试验的经验> 5年 在重病的孩子中。我们提议的首席研究员Hornik博士致力于 通过开发安全有效的药物，改善重症儿童的结局和 干预措施。 Hornik博士是小儿重症监护医学和心脏病学的董事会认证，已提高 在生物统计学和药物科学方面的培训，以及入学重症儿童的记录 临床试验和心理培训早期研究人员。作为两个部门的教职员工 儿科和杜克临床研究所（DCRI），世界上最大的学术研究 组织，Hornik博士建立了一项研究和领导力组合，非常适合增强科学广度 cpccrn。利用我们的经验协调大型多中心儿科临床研究网络， 包括NICHD资助的儿科试验网络，FDA支持全球小儿临床试验 网络和NCAT的试用创新网络，以及通过划分的资源 定量科学和DCRI药物计量学中心，我们将提供深厚的科学专业知识和 临床药理学领域的CPCCRN研究人员的培训和心理机会 世界证据生成和监管科学。通过我们的临床范围和科学专业知识，我们将 为CPCCRN的成功，才华横溢的临床科学家的发展以及 我们高度创新的临床试验的完整性，旨在降低mod的发病率和死亡率 重病的婴儿和儿童。