EPPIC-NET DCC - Revision

EPPIC-NET DCC - 修订版

• 批准号: 10162224
• 负责人: Eva Petkova
• 金额: $ 133.32万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10162224
• 关键词: 2019-nCoV; Acute; Admission activity; Adult; Ataxia; Bioinformatics; Biological; Biological Markers; Biological Specimen Banks; Biometry; COVID-19; COVID-19 pandemic; Caring; Cataloging; Catalogs; Childhood; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Collection; Common Data Element; Communities; Complement; Coronavirus; Data; Data Aggregation; Data Collection; Data Coordinating Center; Data Management Resources; Data Sources; Data Storage and Retrieval; Databases; Deposition; Development; Disease; Dizziness; Encephalitis; Enrollment; Ensure; Event; FAIR principles; Fostering; Functional disorder; Future; Genomics; Goals; Government; Growth; Headache; Healthcare; Hospitalization; Human Resources; Impairment; Individual; Infection; Institutes; Institution; International; Intervention; Intubation; Knowledge; Leadership; Life Experience; Link; Location; Lung diseases; Maps; Monitor; Myopathy; National Institute of Neurological Disorders and Stroke; Natural History; Neurologic; Neurologic Symptoms; New York; New York City; Occupations; Organism; Oxygen; Pain; Pain Research; Pain management; Parents; Participant; Patient Care; Patients; Performance; Phase; Phase II Clinical Trials; Predisposition; Preparation; Prevalence; Procedures; Process; Protocols documentation; Publishing; Radiology Specialty; Recommendation; Recording of previous events; Reporting; Reproducibility; Research; Research Personnel; Resolution; Resources; Running; Sampling; Secure; Seizures; Shipping; Site; Smell Perception; Source; Specialist; Standardization; Structure; Symptoms; System; Taste Perception; Techniques; Testing; Therapeutic; Time; Training; Travel; Unconscious State; United States; United States National Institutes of Health; Visit; Work; advanced system; base; biobank; cerebrovascular; chronic pain; clinical biomarkers; clinical center; clinical data warehouse; clinical investigation; clinical research site; comorbidity; dashboard; data cleaning; data de-identification; data dictionary; data integration; data management; data sharing; data standards; data warehouse; demographics; design; experience; faculty research; follow-up; individual patient; microbiome; mortality; neuroimaging; novel coronavirus; open source; pandemic disease; pre-clinical; quality assurance; radiological imaging; repository; sharing platform; simulation; skeletal; statistics; user-friendly; virtual; web portal

The Data Coordinating Center (DCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) will be the data and biospecimen manager for pain research within the HEAL Partnership. As such, it will host, manage, standardize, curate, and provide a sharing platform for data and biospecimens for HEAL initiatives, such as the Acute to Chronic Pain Signature initiative and the BACPAC, in addition to EPPIC-Net studies. The DCC will develop and maintain a databank for depositing pre-clinical, clinical, neuroimaging, microbiome, genomics, and other omics biomarker data, will link these data with a repository for biological samples, and will create a platform for teams to work together to analyze and interpret data. Further, the DCC will provide leadership in the statistical design and analysis of EPPIC-Net studies, and will deploy advanced systems and processes for data collection, management, quality assurance, and reporting. The DCC will create, sustain, and continually advance a robust organization for the rapid design, implementation, and performance of high- quality rigorous Phase II clinical trials to test promising therapeutics for pain. The proposed DCC brings together experts from statistics, clinical trials design and simulation, data management, neuroimaging, bioinformatics, genomics, and radiology, and leverages decades of experience instituting and running large data sharing consortia and data coordinating centers. Our aims are to further the goals of EPPIC-Net and the HEAL initiative through: 1) Integration of the DCC within the EPPIC-Net structure and facilitation of the alliance with HEAL partners; 2) Provision of biostatistical expertise, support, and leadership to EPPIC-Net studies; 3) Provision of legacy and de novo secure data storage and comprehensive data management for EPPIC-Net studies; 4) Institution of a pain-related expandable biospecimen repository; and 5) Establishment of the EPPIC- Net DataExchange and BiospecimenExchange to foster the development of non-addictive treatments for pain. The DCC will be structured around four cores: 1) an Administrative Core; 2) a Statistical Core; 3) a Data Core; and 4) a Biospecimen Core. This DCC will work with the EPPIC-Net Clinical Coordinating Center (CCC) and with the Specialized Clinical Centers (SCC, a hub and its spokes/clinics) to educate clinicians and staff in good clinical trial practices for reproducibility of research, and to train them in the data management system and procedures employed in the network. The DCC will provide sites with user-friendly dashboards to monitor their own performance and will promote collegial and supportive relationships with the sites’ personnel to cultivate rigorous and enthusiastic engagement in the conduct of the studies. The DCC will use state-of-the-art concepts and techniques in the acquisition, transfer, storing, management, standardization, linking, and curation of the clinical and biomarker data to launch and maintain the EPPIC Exchange encompassing the DataExchange, and the BiospecimenExchange. The EPPIC Exchange represents the final product delivered by the DCC -- a resource with capability for continual growth, that will be shared by the pain research community.

早期疼痛研究临床网络（EPPIC-Net）的数据协调中心（DCC）将 是数据和生物标本管理器内的疼痛研究愈合的合作伙伴关系。因此，它将主办， 管理，标准化，策展，并提供一个共享平台的数据和生物标本的医疗倡议， 如急性至慢性疼痛特征倡议和BACPAC，以及EPPIC-Net研究。的 DCC将开发和维护一个数据库，用于存储临床前、临床、神经成像、微生物组， 基因组学和其他组学生物标志物数据将把这些数据与生物样本库联系起来， 创建一个平台，让团队一起工作，分析和解释数据。此外，DCC将提供 领导EPPIC网络研究的统计设计和分析，并将部署先进的系统， 数据收集、管理、质量保证和报告流程。DCC将创建，维持， 并不断推进一个强大的组织，以快速设计，实施和性能高， 质量严格的第二阶段临床试验，以测试有前途的疼痛疗法。拟议的DCC带来了 来自统计学、临床试验设计和模拟、数据管理、神经影像学 生物信息学，基因组学和放射学，并利用数十年的经验，建立和运行大型 数据共享联盟和数据协调中心。我们的目标是进一步实现EPPIC网络的目标， 通过以下方式实施保健和教育倡议：1）将发展协调委员会纳入环境、生产和消费者信息中心网络结构，并促进联盟 与HEAL合作伙伴; 2）提供生物统计专业知识，支持和领导EPPIC网络研究; 3） 为EPPIC网络提供传统和重新安全数据存储和全面数据管理 研究; 4）建立疼痛相关的可扩展生物标本库; 5）建立EPPIC- Net DataExchange和BioObservenExchange，以促进非成瘾性疼痛治疗的发展。 发展协调委员会将围绕四个核心结构：（1）行政核心;（2）统计核心;（3）数据核心; 和4）生物样本芯。该DCC将与EPPIC网络临床协调中心（CCC）合作， 与专业临床中心（SCC，一个中心及其分支/诊所）合作，以良好的方式教育临床医生和工作人员 研究再现性的临床试验实践，并在数据管理系统中对他们进行培训， 网络中使用的程序。DCC将为研究中心提供用户友好的仪表板，以监控其 自己的表现，并将促进学院和支持的关系，与网站的人员，以培养 严格和热情地参与研究工作。DCC将使用最先进的概念 和技术的获取，转移，存储，管理，标准化，链接，和策展， 临床和生物标志物数据，以启动和维护包含DataExchange的EPPIC Exchange， 和生物多样性交易所EPPIC交易所代表了DCC交付的最终产品， 资源与能力的持续增长，这将是共享的疼痛研究界。