EPPIC-NET DCC

基本信息

批准号：
10361021
负责人：
Eva Petkova
金额：
$ 2.12万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-06-01 至 2022-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10361021
关键词：
Academia Acute Acute Pain Address Architecture Behavioral Bioinformatics Biological Biological Markers Biological Specimen Banks Biometry Cataloging Charge Chronic Disease Clinic Clinical Clinical Trials Clinical Trials Design Collaborations Collection Communities Computer software Computing Methodologies Data Data Analyses Data Analytics Data Collection Data Coordinating Center Data Management Resources Data Set Data Storage and Retrieval Deposition Development Ensure Fostering Genomics Goals Government Growth Health Helping to End Addiction Long-term Human Resources Image Industry Infrastructure Institutes Institution Leadership Link Maintenance Manuscripts Monitor Pain Pain Research Pain management Participant Patient-Focused Outcomes Patients Performance Pharmacology Phase Phase II Clinical Trials Phenotype Preparation Procedures Process Protocols documentation Public Health Quality Control Radiology Specialty Randomized Reporting Reproducibility Research Research Design Research Personnel Research Proposals Resources Role Running Sample Size Sampling Secure Site Specimen Standardization Statistical Computing Statistical Data Interpretation Structure System Techniques Testing Therapeutic Time Training United States National Institutes of Health Validation Work advanced system base biomarker discovery care outcomes chronic pain clinical biomarkers clinical center clinical investigation complex data computerized tools dashboard data exchange data integration data management data repository data sharing design experience experimental study improved industry partner microbiome neuroimaging new therapeutic target non-opioid analgesic novel patient population phenotypic biomarker pre-clinical psychosocial quality assurance relational database repository sample collection scientific organization sharing platform simulation statistics tool treatment response user-friendly

项目摘要

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）将成为治疗伙伴关系中疼痛研究的数据和生物循环经理。因此，它将托管，管理，标准化，策划并提供数据和生物测量的共享平台，用于治疗计划，除了Eppic-NET研究外，例如慢性疼痛签名计划和BACPAC的急性。这 DCC将开发和维护一个数据库，用于沉积临床前，临床，神经影像学，微生物组，基因组学和其他OMICS生物标志物数据将将这些数据与生物样品存储库联系起来，并将创建一个平台，让团队共同分析和解释数据。此外，DCC将提供在Eppic-NET研究的统计设计和分析中的领导才能，并将部署高级系统和数据收集，管理，质量保证和报告的过程。 DCC将创建，维持，并不断提高一个强大的组织，以快速设计，实施和高度绩效质量严格的II期临床试验，以测试有希望的疼痛疗法。拟议的DCC带来统计，临床试验设计和仿真，数据管理，神经影像学的专家，共同生物信息学，基因组学和放射学，并利用数十年来建立和运行的经验数据共享财团和数据协调中心。我们的目标是进一步促进Eppic-Net的目标和通过：1）DCC在Eppic-NET结构和联盟的设施中的整合：1）与治愈伴侣； 2）为EPPIC-NET研究提供生物统计学专业知识，支持和领导力； 3）为Eppic-NET提供遗产和从头安全的数据存储和全面数据管理研究； 4）与疼痛相关的可扩展生物循环库的制度； 5）建立Eppic- 净dataExchange和biospecimenexchange促进了疼痛的非添加治疗方法的发展。 DCC将在四个核心围绕：1）行政核心； 2）统计核心； 3）数据核心； 4）生物晶体核心。该DCC将与Eppic-Net临床协调中心（CCC）和与专门的临床中心（SCC，一个枢纽及其发言/诊所）一起教育临床医生和员工研究可重复性的临床试验实践，并在数据管理系统中训练它们在网络中执行的程序。 DCC将为网站提供用户友好的仪表板，以监视其自己的表现，并将促进与网站人员的联盟和支持性关系以培养严格而热情地参与研究的行为。 DCC将使用最先进的概念以及收购，转移，存储，管理，标准化，链接和策划和策划的技术临床和生物标志物数据以启动和维护包含数据交换的EPPIC交换，和Biospecimenexchange。 EPPIC交换代表DCC交付的最终产品 - a 具有持续增长能力的资源，这将由疼痛研究界共享。