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存在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。 NICHD 新生儿研究网络 (NRN) 研究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（DCC），它可以提供高质量和公正的生物统计专业知识，帮助 NRN 瞄准其资源并优化其科学影响，方法是：（a）帮助 NRN 确定高度优先的研究主题，（b）为严格且可行的研究（特别是掩盖随机试验及其中期监测）的设计和分析提供客观的统计专业知识，（c）开发 有效利用有限资源的高效流程和系统，(d) 确保研究设计、开发、数据收集和分析的标准化，以及 (e) 研究结果的传播。 RTI 自 1998 年以来一直担任 NRN 的 DCC，并计划在未来 5 年内继续担任这一角色。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来增强网络的科学严谨性，以解决新生儿研究中的独特挑战； （2）通过提供灵活高效的数据和研究管理来优化生产力，促进数据共享、集成和协调； (3) 通过向数据安全和监测委员会报告来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 研究和出版物的研究人员合作； (5) 利用 NRN 基础设施和数据建立外部伙伴关系，支持和扩大网络科学目标； (6) 提供运行高效且富有成效的多中心临床研究网络所需的后勤、通信和监管支持。拟任 DCC PI 的 Abhik Das 博士在新生儿临床研究方面拥有丰富的经验，在过去 12 年中一直领导 NRN DCC。他将得到候补 PI 博士的协助。 Marie Gantz 和 Carla Bann 以及拥有丰富 NRN 经验的员工。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。该应用程序具有帮助推进 NRN 研究议程的独特优势：（1）高素质和积极主动的 PI 和工作人员在新生儿研究（包括现有的 NRN 数据和主动/计划的研究）方面拥有深入的知识和经验，无需额外的培训或资源即可无缝继续 NRN 研究； (2) 经过验证的科学生产力，由 RTI 支持的 NRN 研究和出版物的质量和数量记录，这些研究和出版物改变了临床实践； (3) 最先进的工具、流程和系统基础设施，可根据 NRN 的需求灵活定制； (4) 能够与NRN研究者合作实现研究目标的多学科专家； (5) 为NRN定制的强大的数据采集和管理系统，确保数据质量； (6) 提供最大人员配置灵活性的管理结构，以快速响应不断变化的 NRN 需求。 “这项研究是 NIH 帮助结束成瘾长期 (HEAL) 计划的一部分，旨在加快科学解决国家阿片类药物公共卫生危机的方案。NIH HEAL 计划支持整个 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，以遏制国家阿片类药物公共卫生危机。”