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: 9983354
• 负责人: Abhik Das
• 金额: $ 675万
• 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/9983354
• 关键词: Address; Bioinformatics; Biometry; Clinical; Clinical Research; Clinical Trials; Collaborations; Communication; Custom; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; 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 practice; data management; 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.

项目概要 新生儿医学证据基础中的关键和持续的差距需要创新和严格的 多中心研究来解决这些问题。 NICHD 新生儿研究网络 (NRN) 调查安全性 新生儿治疗和管理策略的有效性。迫切需要一个 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专业知识 通过 (a) 帮助 NRN 确定研究，帮助 NRN 瞄准其资源并优化其科学影响 高度优先的主题，(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（特别是隐蔽随机试验及其中期监测），(c) 开发有效的 有效利用有限资源的流程和系统，(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 年起担任 NRN 并提议在未来 5 年内继续担任这一职务。我们将最大化 NRN 科学 通过 (1) 通过创新的试验设计和统计提高网络的科学严谨性 解决新生儿研究中独特挑战的方法； (2) 通过提供优化生产力 灵活高效的数据和研究管理，促进数据共享、集成和协调； (3) 通过向数据安全和监测部门报告来保护参与者的安全和研究的完整性 委员会; (4) 提供及时的数据分析，与所有 NRN 研究的研究者合作， 出版物； (5) 利用 NRN 基础设施和数据来支持和扩大外部合作伙伴关系 网络科学目标； (6) 提供必要的后勤、通讯和监管支持 运行高效且富有成效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拥有丰富的经验，过去 12 年一直领导 NRN DCC。他将会是 由候补 PI 博士协助。 Marie Gantz 和 Carla Bann 以及拥有丰富 NRN 经验的员工。消息灵通 根据我们过去的成就，我们将支持 NRN 在推进基于证据的方面继续取得成功 新生儿护理。该应用程序具有独特的优势，可以帮助推进 NRN 研究议程：(1) 合格且积极主动的 PI 以及在新生儿研究方面拥有深入知识和经验的工作人员（包括 现有的 NRN 数据和正在进行的/计划中的研究），使 NRN 研究能够无缝继续，而无需 额外的培训或资源； (2) 经证实的科学生产力，由质量和数量记录 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 的需求灵活定制的工具、流程和系统基础设施； (4) 多学科专家可以与 NRN 研究人员合作实现研究目标； (5) 稳健的数据 为 NRN 定制的捕获和管理系统，确保数据质量； (6) 行政 结构提供最大的人员配置灵活性，以快速响应不断变化的 NRN 需求。