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

项目总结/摘要 新生儿研究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）的下一章视为其“主要和第一线”， 基础设施”，用于在新生儿中进行确定性、严格性和可重复性的多中心临床研究 产生证据来指导临床实践。我们需要一个独立的数据库。 协调中心（DCC）提供复杂和公正的生物统计和操作专业知识， 帮助NRN瞄准其资源，并通过以下方式优化其科学影响：（1）帮助确定研究主题， 高度优先，（2）提供客观的统计专门知识，以设计和分析严格可行的 研究，（3）开发流程和系统，以提高效率和优化有效使用 通过外部伙伴关系扩大NRN的科学目标，（4）确保 研究设计、开发、数据收集和分析的标准化;（5）传播结果。 自1998年以来，RTI一直是NRN的DCC，并计划在未来7年继续担任这一角色。我们 将通过以下方式最大限度地发挥NRN的科学影响：（1）合作开发严格的 创新的试验设计和统计方法，以应对新生儿研究中的独特挑战;（2） 通过提供灵活高效的数据/项目管理和研究监测来优化生产力，以及 促进数据共享、整合和协调;（3）积极寻求外部伙伴关系， 支持和扩大NRN科学目标;（4）保护参与者安全和研究完整性;（5）提供 为所有NRN研究提供及时的数据分析和协作传播;以及（6）提供后勤， 沟通和监管支持，以运行高效和富有成效的多中心临床试验 研究网络。拟定PI Abhik Das博士在新生儿临床研究方面具有丰富的经验， 在过去的17年里领导着NRN DCC。他将由候补PI Carla班恩博士和工作人员协助 具有丰富的NRN经验。该应用程序具有独特的优势，有助于推进NRN研究 议程：（1）一个高素质和积极性的PI和工作人员，具有深入的知识和多年的经验， 新生儿研究需求，使NRN研究能够在没有额外培训的情况下无缝继续， （2）在NRN的质量和数量中记录的科学生产力的证明记录 RTI支持的研究和出版物改变了临床实践，并利用NRN 推进NICHD和NRN科学目标的基础设施;（3）最先进的工具基础设施， 流程和系统是灵活的，并根据NRN的需求定制;（4）多学科 可以与NRN研究人员合作实现研究目标的专家;（5）强大的数据管理 为NRN定制的系统，确保数据质量;（6）灵活的管理结构， 最大的灵活性，人员配备和合同业务，以迅速响应不断变化的NRN的需求。

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.