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: 10375431
• 负责人: Abhik Das
• 金额: $ 670万
• 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/10375431
• 关键词: Address; Bioinformatics; Biometry; Clinical Research; Clinical Trials; Collaborations; Communication; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Management Resources; Data Reporting; Development; Ensure; Exhibits; Feasibility Studies; Goals; Helping to End Addiction Long-term; Human Resources; Infrastructure; Institution; Institutional Review Boards; Knowledge; Lead; Leadership; Letters; Masks; Medicine; Mission; Monitor; Multicenter Neonatal Research Network; Multicenter Studies; National Institute of Child Health and Human Development; Neonatal; Network Infrastructure; Newborn Infant; Opiate Addiction; Opioid; Performance; Perinatal; Play; Population; Principal Investigator; Process; Productivity; Protocols documentation; Public Health; Publications; Qualifying; Quality Control; Recording of previous events; Reporting; Research; Research Design; Research Personnel; Research Priority; Research Support; Resources; Role; Running; Safety; Services; Site; Speed; Standardization; Statistical Data Interpretation; Statistical Methods; Structure; System; Technology Transfer; Training; Treatment Efficacy; United States National Institutes of Health; Work; clinical center; clinical practice; data management; data quality; data sharing; design; electronic data; evidence base; experience; flexibility; health economics; human subject; improved; innovation; interoperability; meetings; multidisciplinary; neonatal care; opioid misuse; participant safety; programs; quality assurance; randomized trial; stem; success; symposium; tool; treatment strategy; trial design

: 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. “This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to improve treatment for opioid misuse and addiction. This study will continue to build the evidence-basis for better treatment of opioid misuse and addiction in order to stem the national opioid public health crisis.”

： 新生儿医学的证据基础上的关键和持续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）调查了新生婴儿的治疗和管理策略的安全性和有效性。对于独立的数据协调中心（DCC）的至关重要需求，该中心可以提供高质量和公正的生物统计学专业知识，以帮助NRN针对其资源，并通过（a）帮助NRN确定高优先级的研究主题（a），（b）提供了对严格的和分析性的研究（尤其是对经过良好的研究）（尤其是对经过的研究）（尤其是对经过的研究）（尤其是对经过良好的研究）（尤其是效率（b））（a）。有效利用有限资源的有效过程和系统，（d）确保研究设计，开发，数据收集和分析以及（e）研究结果的标准化。 RTI通过（1）通过创新的试验设计和统计方法来提高网络的科学严谨性，从而最大程度地提高NRN科学生产力，以解决新生儿研究中独特的挑战； （2）通过提供灵活有效的数据和研究管理以及促进数据共享，集成和协调来优化生产率； （3）通过向数据安全和监测委员会的报告来保护参与安全和研究完整性； （4）提供及时的数据分析，与所有NRN研究和出版物的研究人员合作； （5）利用NRN基础架构和数据来支持支持和扩大网络科学目标的外部伙伴关系； （6）提供有效且富有生产力的多中心临床研究网络所需的物流，通信和监管支持。拟议的DCC PI Abhik Das博士在新生儿临床研究中拥有丰富的经验，在过去的12年中，NRN DCC领导了NRN DCC。他将得到替代PIS DR的协助。玛丽·甘茨（Marie Gantz）和卡拉·班恩（Carla Bann）以及具有丰富的NRN经验的员工。在过去的成就中，我们将支持NRN在推进基于证据的新生儿护理方面的持续成功。该应用程序具有独特的优势，可以帮助推进NRN研究议程：（1）具有新生儿研究（包括现有的NRN数据和活跃/计划研究）的高度合格且成熟的PI和员工，在没有其他培训或资源的情况下实现了无缝的NRN研究延续； （2）经过证明的科学生产力，记录了RTI支持的NRN研究和出版物的质量和数量，这些研究和出版物改变了临床实践； （3）工具，流程和系统的最新基础架构灵活并根据NRN的需求进行定制； （4）可以与NRN研究人员合作以实现研究目标的多学科专家； （5）为NRN定制的可靠数据捕获和管理系统，以确保数据质量； （6）行政结构提供最大的人员配备灵活性，以迅速响应不断变化的NRN需求。 “这项研究是NIH的一部分，有助于结束长期（治愈）的倡议，以加快阿片类阿片类公共卫生危机的科学解决方案。NIHHeal Heal Initiative Bolsters跨NIH的研究以改善对阿片类药物滥用和成瘾的治疗。这项研究将继续建立对阿片类滥用和成瘾的证据，以使阿片类滥用和成瘾的危机构成危机危机危机。