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

项目摘要/摘要 新生儿研究的关键差距需要多中心的参与和创新的设计来研究它们。 NICHD将其新生儿研究网络(NRN)的下一章视为其“主要和第一线” 用于对新生儿进行权威、严谨和可重复的多中心临床研究的基础设施 这就产生了指导临床实践的证据。迫切需要一个独立的数据 协调中心(DCC)提供复杂和公正的生物统计和操作专业知识， 通过(1)帮助确定以下研究主题，帮助NRN确定其资源目标并优化其科学影响 高度优先，(2)为严谨和可行的设计和分析提供客观的统计专门知识 研究，(3)开发流程和系统，以提高效率和优化有效利用 通过扩大自然资源分配网络科学目标的外部伙伴关系提供有限的资源，(4)确保 研究设计、开发、数据收集和分析的标准化，以及(5)传播结果。 RTI自1998年以来一直担任NRN的DCC，并提议在未来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)合作开发严谨和 创新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/项目管理和研究监控来优化工作效率，以及 促进数据共享、整合和协调；(3)积极寻求外部伙伴关系，以 支持和放大NRN的科学目标；(4)保护参与者的安全和研究的完整性；(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、 运营高效、高效的多中心诊所所需的通信和监管支持 研究网络。Abhik Das博士，拟议的PI，在新生儿临床研究方面拥有丰富的经验， 在过去的17年里领导NRN DCC。他将由候补派、卡拉·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)高素质和上进心的私人助理和具有深入知识和多年经验的工作人员 新生儿研究需求，实现NRN研究的无缝延续，无需额外培训或 资源；(2)以自然资源的质量和数量记录的科学生产力的可靠跟踪记录 由RTI支持的改变了临床实践并利用NRN的研究和出版物 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， 灵活的流程和系统，并根据国家资源规划网络的需要进行定制； 能够与NRN调查人员协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；以及(6)灵活的管理结构，提供 在人员配置和合同业务方面具有最大的灵活性，以快速响应不断变化的NRN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.