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: 10670216
• 负责人: Christoph Hornik
• 金额: $ 15.85万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-18 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10670216
• 关键词: Collaborative; Pediatric; Critical; Care; Research

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大的协作式儿科危重护理的总体目标 研究网络(CPCCRN)作为一个新的站点，是为了增强网络的科学广度和覆盖范围，以 最大限度地发挥其对公共卫生的影响，改善危重儿童的结局。我们的网站，由Duke组成 北卡罗来纳州达勒姆大学(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，为每人4000名危重儿童提供全面护理 在两个州都是如此。我们的网站提供89张儿科重症监护病床，我们将共同努力 确保卡罗莱纳州所有危重儿童都能获得尖端临床试验和研究 CPCCRN进行的研究。我们致力于通过以下途径改善危重儿童的结局 多中心协作临床研究。在过去的3年里，我们招收了400名危重儿童 15项临床研究在杜克大学进行，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广泛的临床医学科室和学院的支持 提供全方位服务的行政、财务、监管和科学支持的研究基础设施。我们的 拟任的研究协调员哈沃德女士有5年管理多中心临床试验的经验 在危重儿童身上。我们推荐的首席调查员霍尼克博士将他的职业生涯奉献给 通过开发安全有效的药物和改善危重儿童的预后 干预措施。霍尼克医生是儿科重症监护医学和心脏病学的董事会认证， 生物统计学和药学方面的培训，以及让危重儿童参加 临床试验和指导职业生涯早期的研究人员。作为一名教职员工，这两个系 儿科学和杜克临床研究所(DCRI)，世界上最大的学术研究 作为一个组织，霍尼克博士建立了一个研究和领导组合，非常适合提高科学广度 CPCCRN的。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支持全球儿科临床试验 网络和NCATS试验创新网络，以及可通过 定量科学和DCRI药物计量学中心，我们将提供深厚的科学知识和 在临床药理学、真实世界证据生成和监管科学领域为CPCCRN调查人员提供培训和指导机会。通过我们的临床覆盖范围和科学专业知识，我们将 为CPCCRN的成功做出重大贡献，培养有才华的临床医生科学家，以及 我们高度创新的临床试验的完成，旨在降低MODS的发病率和死亡率 危重婴儿和儿童。