Statistical Methods to Jointly Model Multiple Pain Outcome Measures

早期疼痛调查临床网络的数据协调中心(DCC)将 在Hear合作伙伴关系中担任疼痛研究的数据和生物制品经理。因此，它将主办， 为Hear计划管理、标准化、管理和提供数据和生物样品的共享平台， 例如急性到慢性疼痛征兆倡议和BACPAC，以及EPPIC-Net研究。这个 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记物数据将把这些数据与生物样本储存库联系起来，并将 为团队创建一个共同分析和解释数据的平台。此外，DCC将提供 在EPPIC-Net研究的统计设计和分析方面处于领先地位，并将部署先进的系统和 数据收集、管理、质量保证和报告流程。DCC将创建、维持、 并不断推进强大的组织，以快速设计、实施和执行高 高质量的严格的第二阶段临床试验，以测试有前景的疼痛疗法。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、神经成像、 生物信息学、基因组学和放射学，并利用数十年的经验制定和运行大型 数据共享联合体和数据协调中心。我们的目标是推动EPPIC-Net和 通过：1)将DCC整合到EPPIC-Net结构中，促进联盟的发展 与Hear合作伙伴；2)为EPPIC-Net研究提供生物统计学专业知识、支持和领导；3) 为EPPIC-Net提供遗留和从头开始的安全数据存储和全面数据管理 研究；4)建立与疼痛相关的可扩展的生物谱系信息库；以及5)建立EPPIC- Net DataExchange和BiopecimenExchange，以促进非成瘾性疼痛治疗的开发。 DCC将围绕四个核心构成：1)行政核心；2)统计核心；3)数据核心； 4)生态型岩芯。DCC将与EPPIC-Net临床协调中心(CCC)和 与专门的临床中心(SCC及其分支机构/诊所)合作，对临床医生和工作人员进行良好的培训 临床试验做法，以确保研究的重现性，并在数据管理系统和 网络中采用的程序。DCC将为站点提供用户友好的仪表板，以监控其 自己的表现，并将促进与现场人员的合作和支持关系，以培养 严谨而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、链接和管理 临床和生物标记物数据，以启动和维护EPPIC交换，包括数据交换， 和生物制品交易所。EPPIC交易所代表DCC交付的最终产品--a 具有持续增长能力的资源，将由疼痛研究社区共享。

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.