Collaborative Pediatric Critical Care Research Network - Data Coordinating Center

儿科重症监护协作研究网络 - 数据协调中心

• 批准号: 10670224
• 负责人: Jonathan Michael Dean
• 金额: $ 141.69万
• 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/10670224
• 关键词: Accounting; Applied Research; Award; Biological; Biometry; Child; Childhood; Clinical; Clinical Investigator; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Communication Tools; Critical Care; Critically ill children; Data Collection; Data Coordinating Center; Data Set; Development; Emergency Care; Enrollment; Funding; Heart Arrest; Infant; Informatics; Institution; Institutional Review Boards; International; Leadership; Manuals; Medical; Medical Informatics; Methods; Monitor; Morbidity - disease rate; Multiple Organ Failure; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; Observational Study; Occupational activity of managing finances; Pediatric Intensive Care Units; Peer Review; Performance; Pharmaceutical Preparations; Pharmacology; Play; Principal Investigator; Production; Productivity; Protocols documentation; Publications; Qualifying; Randomized, Controlled Trials; Reporting; Research; Research Personnel; Role; Sepsis; Site; Specimen; Technology; Testing; Therapeutic; Training; Universities; Utah; clinical research site; data harmonization; data management; design; expectation; experience; human subject protection; immune function; immunoregulation; informatics tool; innovation; medical schools; mortality; natural hypothermia; operation; pediatric emergency; pediatric pharmacology; tool development; trial design

Project Summary In 2005, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Collaborative Pediatric Critical Care Research Network (CPCCRN) to support multi-institutional randomized controlled trials (RCTs) and observational studies in critically ill children. The University of Utah is prepared to support the proposed expansion of CPCCRN from seven clinical sites to 24 sites, which will en- able CPCCRN to carry out the Personalized Immunomodulation in Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) study. The DCC will play an important independent role in assuring regulatory compliance, human subjects protection, and integrity of the trial results. The DCC has two Specific Aims: (1) Provide independent clinical and biostatistical leadership and expertise, assistance in study and protocol design, study implementation and management, tracking and delivery methods for study drugs and biological specimens, study training, data collection and management, site monitoring, study reporting, interim and final study analyses, publication of study results, and production of public use research datasets. (2) Provide logistical support for CPCCRN (including financial management of protocol funds), us- ing advanced communication and informatics tools for development and tracking of critical documents, including study protocols, FAQ documents, Manuals of Operation, training materials, IRB and other regulatory documents, study publications, DSMB reports, and provision of accounting information to NICHD. The DCC has played a crucial leadership role during the first 15 years of the CPCCRN. Clinical expertise has enabled efficient design and prioritization of CPCCRN studies to maximize productivity; biostatistical expertise has been provided at every stage of study development and implementation; state of the art informatics tech- nology has enabled efficient communication within CPCCRN since its inception. We believe that the primary criterion by which a DCC should be judged is the productivity of the sites and investigators supported by the DCC. Investigators have successfully competed for nine R01 awards to increase the productivity of CPCCRN, implementing 36 studies resulting in 119 peer reviewed publications. The CPCCRN will continue its outstanding performance with the unique strengths that are contributed from the University of Utah DCC.

项目摘要 2005年，尤尼斯·肯尼迪·施莱佛国家儿童健康和人类发展研究所（NICHD） 建立了合作儿科重症监护研究网络（CPCCRN），以支持多机构 在重症儿童中进行的随机对照试验（RCT）和观察性研究。犹他州大学是 准备支持将CPCCRN从7个临床站点扩展到24个站点的建议，这将- CPCCRN对脓毒症所致多器官功能障碍的个体化免疫调节 综合征（MODS）研究。DCC将在确保法规遵从性方面发挥重要的独立作用， 人类受试者保护和试验结果的完整性。 DCC有两个具体目标：（1）提供独立的临床和生物统计领导和专业知识， 协助研究和方案设计、研究实施和管理、跟踪和交付方法 研究药物和生物标本、研究培训、数据收集和管理、研究中心监查、研究 报告、中期和最终研究分析、研究结果的出版以及公共使用研究成果的制作 数据集。(2)为CPCCRN提供后勤支持（包括方案资金的财务管理），我们- 使用先进的通信和信息学工具来编制和跟踪重要文件，包括 研究方案、常见问题解答文件、操作手册、培训材料、IRB和其他监管文件， 研究出版物、DSMB报告和向NICHD提供会计信息。 在CPCCRN成立的前15年，DCC发挥了关键的领导作用。临床专业知识 使CPCCRN研究的有效设计和优先排序能够最大限度地提高生产率;生物统计学专业知识 在研究开发和实施的每个阶段都提供了最先进的信息技术， 自CPCCRN成立以来，nology使其内部能够进行有效沟通。我们认为， 判定DCC的标准是研究中心和研究者的工作效率， DCC。调查人员已经成功地竞争了九个R 01奖项，以提高CPCCRN的生产力， 开展了36项研究，产生了119份同行评审出版物。CPCCRN将继续其杰出的 性能与独特的优势，是从犹他州DCC贡献的大学。