Collaborative Pediatric Critical Care Research Network - Clinical Site

儿科重症监护协作研究网络 - 临床网站

基本信息

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
项目类别：
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

项目摘要

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 - 杜克大学我们的总体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）作为一个新网站，旨在增强网络的科学广度和覆盖范围，最大限度地发挥其公共卫生影响并改善危重儿童的治疗结果我们的网站由杜克大学组成。北卡罗来纳州达勒姆大学（主校区）和南卡罗来纳医科大学（MUSC；位于南卡罗来纳州查尔斯顿的附属站点）为每 4000 名危重儿童提供全面护理今年，我们的网站将在这两个州提供 89 张联合儿科重症监护床位。确保卡罗莱纳州所有危重儿童都能获得最先进的临床试验和研究我们致力于通过 CPCCRN 进行的研究来改善危重儿童的治疗结果。在过去的 3 年里，我们已经招募了超过 400 名危重儿童。 15 项临床研究在杜克大学进行，并由我们领先的多中心临床研究网络协调。现场研究团队得到了综合部门和医学院广泛临床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。拟议的研究协调员 Harward 女士拥有超过 5 年的多中心临床试验经验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重症儿童。通过开发安全有效的药物来改善危重儿童的治疗结果霍尼克博士获得了儿科重症监护医学和心脏病学委员会的认证，在干预方面取得了进展。生物统计学和制药科学方面的培训，以及招收危重儿童的记录作为两个系的教员，进行临床试验和指导早期职业研究人员。儿科和世界上最大的学术研究杜克临床研究所 (DCRI) 霍尼克博士建立了一个非常适合增强科学广度的研究和领导组合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、NCATS 试验创新网络，以及通过该部门获取的资源定量科学和 DCRI 药物计量中心，我们将提供深厚的科学专业知识和为 CPCCRN 研究人员提供临床药理学、实际应用领域的培训和指导机会通过我们的临床影响力和科学专业知识，我们将生成世界证据和监管科学。为 CPCCRN 的成功、才华横溢的临床科学家的发展做出了重大贡献，完成我们高度创新的临床试验，旨在降低 MODS 的发病率和死亡率危重婴儿和儿童。