Data Coordinating Center for the NICHD Neonatal Research Network (U24)

NICHD 新生儿研究网络数据协调中心 (U24)

• 批准号: 9898399
• 负责人: Abhik Das
• 金额: $ 670万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9898399
• 关键词: Address; Bioinformatics; Biometry; Clinical Research; Clinical Trials; Collaborations; Communication; Custom; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Management Resources; Data Reporting; Development; Ensure; Exhibits; Feasibility Studies; Goals; Human Resources; Infrastructure; Institution; Institutional Review Boards; Knowledge; Lead; Leadership; Letters; Logistics; Masks; Medicine; Mission; Monitor; Multicenter Neonatal Research Network; Multicenter Studies; National Institute of Child Health and Human Development; Neonatal; Network Infrastructure; Newborn Infant; Performance; Perinatal; Play; Population; Principal Investigator; Process; Productivity; Protocols documentation; Publications; Quality Control; Recording of previous events; Reporting; Research; Research Design; Research Personnel; Research Priority; Research Support; Resources; Role; Running; Safety; Services; Site; Standardization; Statistical Data Interpretation; Statistical Methods; Structure; System; Technology Transfer; Time; Training; Treatment Efficacy; Work; clinical center; clinical practice; data management; data quality; data sharing; design; electronic data; evidence base; experience; flexibility; health economics; human subject; innovation; interoperability; meetings; multidisciplinary; neonatal care; participant safety; programs; quality assurance; randomized trial; safety study; success; symposium; tool; treatment strategy; trial design

Project Summary Critical and persistent gaps in the evidence base for neonatal medicine require innovative and rigorous multicenter studies to address them. The NICHD Neonatal Research Network (NRN) investigates the safety and efficacy of treatment and management strategies for newborn infants. There is a crucial need for an independent Data Coordinating Center (DCC) that can provide high-quality and impartial biostatistical expertise to help the NRN target its resources and optimize its scientific impact by (a) helping the NRN identify research topics of high priority, (b) providing objective statistical expertise for the design and analyses of rigorous and feasible studies (especially masked randomized trials and interim monitoring thereof), (c) developing efficient processes and systems for effective use of limited resources, (d) ensuring standardization of study design, development, data collection, and analyses, and (e) dissemination of study results. RTI has been the DCC for the NRN since 1998 and proposes to continue in this role for the next 5 years. We will maximize NRN scientific productivity by (1) enhancing the scientific rigor of the Network with innovative trial designs and statistical methods that address the unique challenges in neonatal research; (2) optimizing productivity by providing flexible and efficient data and study management, and promoting data sharing, integration and harmonization; (3) protecting participant safety and study integrity through reports to the Data Safety and Monitoring Committee; (4) providing timely data analysis, collaborating with investigators on all NRN studies and publications; (5) leveraging the NRN infrastructure and data for external partnerships that support and amplify Network scientific goals; and (6) providing the logistical, communications, and regulatory support necessary to run an efficient and productive multicenter clinical research network. Dr. Abhik Das, the proposed DCC PI, has extensive experience in neonatal clinical studies, leading the NRN DCC for the past 12 years. He will be assisted by Alternate PIs Drs. Marie Gantz and Carla Bann and staff with significant NRN experience. Informed by our past accomplishments, we will support continued success of the NRN in advancing evidence-based neonatal care. This application has unique strengths to help advance the NRN research agenda: (1) a highly qualified and motivated PI and staff with in-depth knowledge and experience in neonatal research (including existing NRN data and active/planned studies), enabling seamless continuation of NRN research without additional training or resources; (2) proven scientific productivity, documented by the quality and quantity of NRN studies and publications supported by RTI that have changed clinical practice; (3) a state-of-the-art infrastructure of tools, processes, and systems that are flexible and customized to the needs of the NRN; (4) multidisciplinary experts who can collaborate with NRN Investigators to realize research goals; (5) robust data capture and management systems customized for the NRN that ensure data quality; and (6) an administrative structure providing maximum staffing flexibility to respond quickly to changing NRN needs.

项目摘要 新生儿医学的证据基础中的关键和持续差距需要创新和严格 多中心研究以解决它们。 NICHD新生儿研究网络（NRN）研究了安全性 以及对新生婴儿的治疗和管理策略的功效。对于一个至关重要的 独立的数据协调中心（DCC），可以提供高质量和公正的生物统计学专业知识 通过（a）帮助NRN确定研究 优先级的主题，（b）为严格和分析的设计和分析提供客观的统计专业知识 可行的研究（尤其是掩盖的随机试验和临时监测），（c）提高有效的 有效利用有限资源的过程和系统，（d）确保研究设计的标准化， 开发，数据收集和分析以及（e）研究结果的传播。 RTI一直是DCC 自1998年以来，NRN提议在接下来的5年中继续担任这一职务。我们将最大化NRN科学 通过（1）通过创新的试验设计和统计来增强网络的科学严谨性的生产率 解决新生儿研究中独特挑战的方法； （2）通过提供优化生产率 灵活，有效的数据和研究管理，并促进数据共享，集成和协调； （3）通过向数据安全和监视来保护参与者的安全和研究完整性 委员会; （4）提供及时的数据分析，与研究人员合作所有NRN研究和 出版物； （5）利用NRN基础架构和数据来支持和放大 网络科学目标； （6）提供必要的后勤，沟通和监管支持 运行有效且富有生产力的多中心临床研究网络。拟议的DCC PI Abhik Das博士 在新生儿临床研究方面的丰富经验，在过去的12年中领导了NRN DCC。他会的 在替代PIS DRS的协助下。玛丽·甘茨（Marie Gantz）和卡拉·班恩（Carla Bann）以及具有丰富的NRN经验的员工。通知 根据我们过去的成就，我们将支持NRN的持续成功，以推动基于证据 新生儿护理。该应用具有独特的优势，可以帮助推进NRN研究议程：（1）高度 具有深入的新生儿研究知识和经验的合格和积极的PI和员工（包括 现有的NRN数据和主动/计划的研究），无需NRN研究的无缝延续 额外的培训或资源； （2）经过证明的科学生产力，记录在质量和数量 RTI支持的NRN研究和出版物改变了临床实践； （3）最先进的 根据NRN的需求灵活和自定义的工具，过程和系统的基础架构； （4） 可以与NRN研究人员合作以实现研究目标的多学科专家； （5）强大的数据 捕获和管理系统为NRN定制，以确保数据质量； （6）行政 结构可提供最大的人员配备灵活性，以迅速响应不断变化的NRN需求。