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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/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“主要和一线” 基础设施”，用于对新生儿进行明确的、严格的、可重复的多中心临床研究生成证据来指导临床实践迫切需要独立的数据。协调中心 (DCC) 提供复杂且公正的生物统计和操作专业知识，通过 (1) 帮助确定以下方面的研究主题，帮助 NRN 瞄准其资源并优化其科学影响：高度优先，（2）为严格可行的设计和分析提供客观的统计专业知识研究，(3) 开发流程和系统以提高效率并优化有效利用通过扩大 NRN 科学目标的外部伙伴关系来利用有限的资源，(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，并建议在未来 7 年内继续担任这一角色。将通过以下方式最大限度地发挥 NRN 的科学影响：(1) 合作开发严格且可靠的创新试验设计和统计方法，应对新生儿研究的独特挑战（2）通过提供灵活高效的数据/项目管理和研究监控来优化生产力，以及促进数据共享、集成和协调；(3) 积极寻求外部合作伙伴关系，支持和扩大 NRN 的科学目标；(4) 保护参与者的安全和研究完整性；(5) 提供为所有 NRN 研究提供及时的数据分析和协作传播；(6) 提供后勤、运行高效且富有成效的多中心临床所需的通信和监管支持拟议的 PI Abhik Das 博士在新生儿临床研究方面拥有丰富的经验，他在过去 17 年里一直领导 NRN DCC，并得到候补 PI Carla Bann 博士和工作人员的协助。具有丰富的 NRN 经验。该应用程序具有帮助推进 NRN 研究的独特优势。议程：（1）高素质、积极主动的 PI 和员工，拥有深厚的知识和多年的经验新生儿研究需求，无需额外培训即可无缝继续 NRN 研究，或资源；(2) NRN 的质量和数量中记录的科学生产力的可靠记录 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， (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，提供人员配置和合同运营方面的最大灵活性，以快速响应不断变化的 NRN 需求。