Consortium on Translational Research in Early Detection of Liver Cancer:Data Management and Coordinating Center (DMCC)

项目总结摘要 肝癌早期检测转化研究联合体(联合体)成功的关键 在于多学科科学家之间的良好沟通，高效的评估和优先顺序 前景看好的生物标记物，以及严格的验证研究，以证明它们在改善 监测和早期发现肝癌，并对肝硬变患者的肝癌风险进行分层。 拟议数据管理和协调中心(DMCC)的总体目标是：(1)加强 财团调查人员之间的沟通和合作；(2)协调财团合作 研究并提供统计支持；(3)开发和维持综合研究和生物库 联盟研究数据库；以及(4)支持和促进跨联盟的合作研究。 在财团指导委员会的指导下，DMCC将1)进行网络协调和 通过为联盟会议和 电话会议，拟定和维护所有联合体文件，包括《操作手册》和 程序(MOP)，并维护和加强财团的安全网站；2)支持财团 通过与联合会调查人员在研究设计、方案开发、数据方面的合作进行研究 表格和研究手册；协调和监测研究；跟踪标本共享、盲法和 随机化；进行QA/QC和研究评估；3)维护和增强指南针数据 用于促进联盟协作活动的管理系统(CDMS)。CDMS提供在线、终端 端到端数据管理解决方案，包括调查员和研究协调员通信、监管 合规性、远程受试者注册、临床数据捕获、生物样品管理、成像数据 存储库和文档管理。CDMS可以为所有用户提供分析数据集的在线可视化 参与研究人员，以及与联盟研究相关的统计和信息学工具；4)支持和 通过促进团队科学，监控研究程序，促进跨联盟合作研究 使用尖端的统计、计算和人工智能方法，确保高效而严谨 研究设计和最大限度地提高研究产出。 我们的研究策略建立在这样的指导原则之上：为财团提供最高质量的服务 同时保持创新并提供科学领导，帮助财团实现其使命。我们的 资格包括自早期发现研究网络成立以来担任DMCC，担任 美国正在进行的两项最大规模的肝硬变队列研究的首席统计学家，并负责 两个FDA批准的成像AI产品和早期检测研究中的许多统计创新。

PROJECT SUMMARY ABSTRACT The key to success of the Consortium on Translational Research in Early Detection of Liver Cancer (Consortium) lies in good communication among scientists in multiple disciplines, efficient evaluation and prioritization of promising biomarkers, and rigorous validation studies to demonstrate their potential clinical utilities in improving the surveillance and early detection of liver cancer and stratifying the risk of liver cancer in patients with cirrhosis. The overall aims of the proposed Data Management and Coordinating Center (DMCC) are to (i) enhance communication and collaboration among Consortium investigators; (ii) coordinate Consortium collaborative research and provide statistical support; (iii) develop and maintain integrated research and biorepository databases for Consortium studies; and (iv) support and facilitate trans-Consortium collaborative research. Under the direction of the Consortium Steering Committee, the DMCC will 1) perform network coordination and promote collaborations among scientific investigators by providing support for Consortium meetings and conference calls, developing and maintaining all Consortium documents, including the Manual of Operations and Procedures (MOP), and by maintaining and enhancing the Consortium’s secure website; 2) support Consortium collaborative studies by working with Consortium investigators on study design, protocol development, data forms, and study manuals; coordinating and monitoring studies; tracking specimen sharing, blinding, and randomization; and performing QA/QC and study evaluation; 3) maintain and enhance the COMPASS Data Management System (CDMS) used to facilitate Consortium collaborative activities. CDMS provides online, end- to-end data management solutions, including investigator and study coordinator communications, regulatory compliance, remote subject registration, clinical data capture, biospecimen sample management, imaging data repository, and document management. CDMS can provide online visibility of analytical datasets for all participating researchers, and statistical and informatic tools relevant to Consortium research; 4) support and facilitate trans-Consortium collaborative studies by promoting team science, monitoring study procedures, and using cutting edge statistical, computational, and Artificial Intelligence methods to ensure efficient yet rigorous study design and maximize research outputs. Our research strategy is built from this guiding principle: provide the highest quality service to the Consortium while remaining innovative and providing scientific leadership to help the Consortium achieve its mission. Our qualifications include being the DMCC for the Early Detection Research Network since its inception, serving as lead statisticians for the two largest ongoing cirrhosis cohort studies in this country, and being responsible for two FDA-cleared Imaging AI products and many statistical innovations in early detection research.