Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET)

数据协调中心 (DCC) 新生儿阿片类药物戒断综合征药物治疗比较有效性试验 (NOWS PhaCET)

• 批准号: 10378283
• 负责人: Abhik Das
• 金额: $ 340.27万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10378283
• 关键词: Address; Area; Attention; Behavioral; Biometry; Caregivers; Caring; Child; Child Health; Childhood; Clinical Investigator; Clinical Practice Guideline; Clinical Trials; Clinical Trials Network; Cognitive; Collaborations; Communication; Conceptions; Consensus; Country; Custom; Data; Data Analyses; Data Collection; Data Coordinating Center; Development; Ensure; Goals; Helping to End Addiction Long-term; Hospitals; Human Resources; Informatics; Infrastructure; Institution; Institutional Review Boards; Investigational Drugs; Knowledge; Language; Leadership; Letters; Logistics; Medicine; Methadone; Methodology; Monitor; Morphine; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Neonatal; Neonatal Abstinence Syndrome; Neonatology; Newborn Infant; Office of Administrative Management; Opioid; Outcome; Participant; Perinatal; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacological Treatment; Pharmacology; Play; Population; Principal Investigator; Process; Productivity; Protocols documentation; Public Health; Publications; Publishing; Randomized Controlled Trials; Reporting; Research; Research Design; Research Personnel; Resources; Risk; Role; Safety; Seizures; Site; Sleep; Standardization; Statistical Methods; Structure; Symptoms; System; Time; United States National Institutes of Health; Visual; Vomiting; Weaning; Weight Gain; clinical practice; clinical research site; comparative effectiveness; comparative effectiveness trial; data harmonization; data management; data quality; data sharing; design; evidence base; experience; feasibility trial; feeding; flexibility; follow-up; implementation barriers; multidisciplinary; neonate; opioid epidemic; opioid withdrawal; participant safety; predictive modeling; randomized trial; real time monitoring; response; safety study; success; tool; treatment strategy; trial design

PROJECT SUMMARY/ABSTRACT Major knowledge gaps exist in optimizing pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS), a pressing public health issue. Rigorous, high quality, randomized trials are urgently needed to develop the evidence base and best practices for neonatal medicine in this area. In response, the NICHD Heal Initiative NOWS Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET) consortium will design and implement a multi-center, comparative effectiveness, randomized controlled trial (RCT) to assess the optimal pharmacological treatment for NOWS that informs clinical practice guidelines. There is a crucial need for an independent and experienced Data Coordinating Center (DCC) to provide high-quality and impartial biostatistical expertise to address the substantial methodologic challenges in the design and conduct of such a trial by (1) building consensus to help identify critical methodologic issues; (2) bringing objective statistical expertise to the conception, design, and analyses of a rigorous and feasible randomized trial (with appropriate monitoring); (3) developing processes and systems to increase the efficiency of the consortium, ensure trial feasibility, and effective use of limited trial participants and resources; (4) ensuring standardization of study design, development, data collection, data quality, and data analyses with existing HEAL activities; and (5) dissemination of study results, public reports, and public use data. As longtime DCC for the NICHD Neonatal Research Network (NRN) and the ongoing Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) studies, RTI has successfully collaborated in the design and implementation of 30+ RCTs in neonates informing clinical practice. Our Specific Aims as the DCC for NOWS PhaCET are to (1) Enhance the scientific rigor of the consortium by collaboratively building consensus for a uniform protocol that addresses the unique feasibility and implementation challenges of pharmacological RCTs in NOWS; (2) Optimize productivity with flexible, efficient, and high quality data and study management, and promote HEAL data harmonization and sharing; (3) Protect participant safety and study integrity working with the independent Data Safety and Monitoring Committee (DSMC), single IRB (sIRB), NICHD, and FDA (as needed); (4) Provide timely reporting and data analysis, and collaborate with investigators on all consortium analyses and publications; and (5) Provide the necessary logistical, contractual, communications, and regulatory support. The unique strengths of this application include (1) a highly qualified PI and staff uniquely experienced in all aspects of both neonatal and NOWS trials including neurodevelopmental follow-up; (2) proven track record of collaboration and scientific productivity in perinatal studies; (3) state-of-the-art infrastructure of flexible tools, processes, and systems customized for neonatal/ NOWS RCTs incorporating follow-up; (4) multidisciplinary experts available as needed; and (5) depth and breadth of expert staff with an agile administrative structure that can respond quickly to changing needs.

项目摘要/摘要 在优化新生儿阿片类药物戒断综合征的药理学治疗方面存在主要知识差距 （现在），这是一个紧迫的公共卫生问题。迫切需要严格，高质量的随机试验 在该领域开发新生儿医学的证据基础和最佳实践。作为回应，NICHD Heal Initiative Now现在是药理治疗比较有效性试验（Nows Phacet） 财团将设计和实施多中心，比较有效性，随机对照试验 （RCT）评估现在为临床实践指南提供信息的最佳药理治疗方法。 独立且经验丰富的数据协调中心（DCC）至关重要 高质量和公正的生物统计学专业知识，以应对在 （1）建立共识，以帮助确定关键的方法论问题； （2） 将客观的统计专业知识带入严格且可行的概念，设计和分析 随机试验（适当监控）； （3）开发过程和系统以增加 财团的效率，确保审判可行性以及有效使用有限的试用参与者， 资源; （4）确保研究设计，开发，数据收集，数据质量和数据的标准化 分析现有的治疗活动； （5）分发研究结果，公共报告和公共用途 数据。 NICHD新生儿研究网络（NRN）和正在进行的前进的长期DCC 新生儿阿片类药物提取（ACT）研究的临床试验，RTI已成功合作 在新生儿中的30多种RCT的设计和实施，以告知临床实践。我们的具体目标是 DCC暂时将通过合作建立（1）增强财团的科学严谨性 一项统一协议的共识，该协议解决了独特的可行性和实施挑战 现在的药理学RCT； （2）通过灵活，高效和高质量数据优化生产率，以及 研究管理并促进治疗数据的协调和共享； （3）保护参与者的安全和 研究完整性与独立数据安全和监测委员会（DSMC），单个IRB合作 （SIRB），NICHD和FDA（根据需要）； （4）提供及时的报告和数据分析，并与 所有财团分析和出版物的调查人员； （5）提供必要的后勤， 合同，沟通和监管支持。该应用程序的独特优势包括（1）a 高素质的PI和员工在新生儿的各个方面都有独特的经验和现在的试验 神经发育随访； （2）围产期的合作和科学生产力的验证记录 研究； （3）为新生儿定制的灵活工具，过程和系统的最新基础架构 Nows RCT结合了后续行动； （4）根据需要提供的多学科专家； （5）深度和 具有敏捷的行政结构的专家员工的广度，可以快速响应不断变化的需求。