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.

项目总结/文摘