Neonatal Research Network Data Coordinating Center (DCC) 2023-2028

新生儿研究网络数据协调中心 (DCC) 2023-2028

• 批准号: 10833754
• 负责人: Abhik Das
• 金额: $ 200万
• 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 2030-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10833754
• 关键词: Address; Biometry; Childhood; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communication; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Management Resources; Data Science; Development; Enrollment; Ensure; Feasibility Studies; Funding; Future; Genomics; Goals; Helping to End Addiction Long-term; Human Resources; Hybrids; Infant Development; Informatics; Infrastructure; International; Knowledge; Leadership; Letters; Masks; Milrinone; Monitor; Multicenter Neonatal Research Network; Multicenter Studies; National Institute of Child Health and Human Development; Neonatal; Network Infrastructure; Newborn Infant; Occupational activity of managing finances; Population Heterogeneity; Positioning Attribute; Principal Investigator; Process; Productivity; Protocols documentation; Publications; Publishing; Qualifying; Reporting; Reproducibility; Research; Research Design; Research Personnel; Research Priority; Resources; Role; Running; Safety; Secure; Site; Standardization; Statistical Data Interpretation; Statistical Methods; Structure; System; Training; Treatment Efficacy; United States Food and Drug Administration; United States National Institutes of Health; Weaning; Work; clinical center; clinical practice; clinical research site; computer program; data management; data quality; data sharing; design; evidence base; experience; flexibility; health economics; innovation; multidisciplinary; neonatal care; neonate; operation; participant safety; patient safety; programs; randomized trial; success; tool; trial design; vision development

PROJECT SUMMARY/ABSTRACT Critical gaps in neonatal research require multicenter involvement and innovative designs to study them. NICHD views the next chapter of its Neonatal Research Network (NRN) as its “primary and first-line infrastructure” for conducting definitive, rigorous, and reproducible multicenter clinical research in newborns that generates evidence to guide clinical practice. There is a crucial need for an independent Data Coordinating Center (DCC) to provide sophisticated and impartial biostatistical and operational expertise that helps the NRN target its resources and optimize its scientific impact by (1) helping identify research topics of high priority, (2) providing objective statistical expertise for the design and analyses of rigorous and feasible studies, (3) developing processes and systems to increase efficiencies and optimize effective usage of limited resources through external partnerships that amplify the NRN scientific goals, (4) ensuring standardization of study design, development, data collection and analyses, and (5) disseminating results. RTI has been the DCC for the NRN since 1998 and proposes to continue in this role for the next 7 years. We will maximize the scientific impact of the NRN by (1) collaborating in the development of rigorous and innovative trial designs and statistical methods to address the unique challenges in neonatal research; (2) optimizing productivity by providing flexible and efficient data/project management and study monitoring, and promote data sharing, integration, and harmonization; (3) vigorously pursuing external partnerships to support and amplify NRN scientific goals; (4) protecting participant safety and study integrity; (5) providing timely data analysis and collaborative dissemination for all NRN studies; 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 PI, has extensive experience in neonatal clinical studies, leading the NRN DCC for the past 17 years. He will be assisted by Alternate PI, Dr. Carla Bann, and staff with significant NRN experience. 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 years of experience in neonatal research needs, enabling seamless continuation of NRN research without additional training or resources; (2) proven track record of scientific productivity documented in the quality and quantity of NRN studies and publications supported by RTI that have changed clinical practice, and leveraging the NRN infrastructure to advance NICHD and NRN scientific goals; (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 management systems customized for the NRN that ensure data quality; and (6) an agile administrative structure providing maximum flexibility in staffing and contractual operations to respond quickly to changing NRN needs.

项目摘要/摘要 新生儿研究中的关键差距需要多中心参与和创新设计来研究它们。 NICHD将其新生儿研究网络（NRN）的下一章视为“主要和第一线 用于进行新生儿的确定，严格和可重复的多中心临床研究的基础设施” 这产生了指导临床实践的证据。对独立数据至关重要 协调中心（DCC）提供了复杂和公正的生物统计和运营专家 通过（1）帮助确定研究主题 高优先级，（2）为严格且可行的设计和分析提供客观的统计专业知识 研究，（3）开发过程和系统以提高效率并优化对 通过外部合作伙伴关系来限制资源，以扩大NRN科学目标，（4）确保 研究设计，开发，数据收集和分析以及（5）传播结果的标准化。 自1998年以来，RTI一直是NRN的DCC，并在接下来的7年中继续担任这一职务。我们 （1）合作在严格和 创新的试验设计和统计方法，以应对新生儿研究的独特挑战； （2） 通过提供灵活有效的数据/项目管理和研究监控来优化生产率，以及 促进数据共享，集成和协调； （3）大力追求外部伙伴关系 支持和扩大NRN科学目标； （4）保护参与者的安全和研究完整性； （5）提供 所有NRN研究的及时数据分析和协作传播； （6）提供后勤， 进行高效和产品多中心临床所需的通信和监管支持 研究网络。拟议的PI Abhik Das博士在新生儿临床研究中拥有丰富的经验， 在过去的17年中，领导NRN DCC。他将得到替代Pi，Carla Bann博士和员工的协助 具有丰富的NRN经验。该应用程序具有独特的优势，可以帮助推进NRN研究 Agernda：（1）具有深入知识和多年经验的高素质和成熟的PI和员工 新生儿研究需求，无需其他培训或 资源; （2）在NRN的质量和数量中记录的科学生产力的验证记录 RTI支持的研究和出版物改变了临床实践，并利用了NRN 促进NICHD和NRN科学目标的基础设施； （3）工具的最新基础架构， 根据NRN的需求而灵活和自定义的过程和系统； （4）多学科 可以与NRN调查人员合作以实现研究目标的专家； （5）强大的数据管理 为NRN定制的系统，以确保数据质量； （6）提供的敏捷行政结构 人员配备和转换器操作的最大灵活性，以迅速响应不断变化的NRN需求。