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.”

： 新生儿医学证据基础中的严重和持久的差距需要创新和严格的多中心研究来解决这些差距。NICHD新生儿研究网络(NRN)调查新生儿治疗和管理策略的安全性和有效性。迫切需要一个独立的数据协调中心，它能够提供高质量和公正的生物统计专门知识，以帮助国家资源中心确定其资源的目标，并通过以下方式优化其科学影响：(A)帮助国家资源中心确定高度优先的研究主题；(B)为设计和分析严谨和可行的研究提供客观的统计专业知识(特别是掩蔽随机试验及其临时监测)；(C)开发有效利用有限资源的有效程序和系统；(D)确保研究设计、开发、数据收集和分析的标准化，以及(E)传播研究结果。RTI自1998年以来一直担任NRN的DCC，并提议在未来5年继续担任这一角色。我们将通过以下方式最大限度地提高NRN的科学生产力：(1)通过创新的试验设计和统计方法提高NRN的科学严格性，以应对新生儿研究中的独特挑战；(2)通过提供灵活有效的数据和研究管理，并促进数据共享、整合和协调，优化生产力；(3)通过向数据安全和监测委员会提交报告，保护参与者的安全和研究的完整性；(4)提供及时的数据分析，与所有NRN研究和出版物的调查人员合作；(5)利用NRN的基础设施和数据，用于支持和扩大NRN科学目标的外部伙伴关系；以及(6)提供必要的后勤、通信和监管支持，以运行高效和多产的多中心临床研究网络。Abhik Das博士，被提议的DCC Pi，在新生儿临床研究方面拥有丰富的经验，在过去的12年里领导NRN DCC。他将由候补私人侦探玛丽·甘茨博士和卡拉·班恩博士以及具有丰富NRN经验的工作人员协助。借鉴我们过去的成就，我们将支持NRN在推进循证新生儿护理方面继续取得成功。这一应用程序在帮助推进NRN研究议程方面具有独特的优势：(1)高度合格和积极的PI以及在新生儿研究(包括现有的NRN数据和正在进行/计划的研究)方面具有深入知识和经验的工作人员，使NRN研究能够无缝地继续进行，而无需额外的培训或资源；(2)已证明的科学生产力，通过RTI支持的改变临床实践的NRN研究和出版物的质量和数量来证明；(3)最先进的基础设施，包括灵活和定制以满足NRN需求的工具、过程和系统；(4)能够与NRN调查人员合作实现研究目标的多学科专家；(5)为NRN量身定做的强大的数据捕获和管理系统，以确保数据质量；以及(6)提供最大工作人员灵活性的行政结构，以快速应对不断变化的NRN需求。 “这项研究是NIH帮助结束成瘾长期(Heal)倡议的一部分，该倡议旨在加快科学解决国家阿片类药物公共健康危机。NIH Hear Initiative支持整个NIH的研究，以改善阿片类药物滥用和成瘾的治疗。这项研究将继续为更好地治疗阿片类药物滥用和成瘾奠定证据基础，以遏制全国阿片类药物公共卫生危机。