Clinical Protocol and Data Management

摘要 芝加哥大学医学综合癌症中心使命的重要组成部分 (UCCCC)是为患者提供最好和最个性化的治疗。该计划的总体目标 临床方案和数据管理(CDPM)旨在建立和维护资源和流程，以 集中和集成多学科组成部分和多部门活动 监督广泛的临床试验组合，包括国家合作小组试验、其他NCI/CTEP- 赞助试验和研究人员发起的试验是通过成员的翻译研究开发的。一个 首要的主题是确保妇女、少数民族和儿童在我们的学习中有足够的入学机会。这个 这些行动的骨干是癌症临床试验办公室(CCTO)，它负责)监管 管理所有成人癌症临床试验，b)通过集中的 临床试验管理系统(VELOS EResearch)；c)附属机构协调和监督， 包括7个国家临床试验网络(NCTN)和个性化癌症护理联盟附属机构 网络以及40多个额外的特设机构；以及d)通过集中教育进行质量控制 和培训，以及正式的数据和安全监测。我们有完善的指导方针和培训 新任监管管理人员入职手册，以及一个带有培训视频的中央网站， 参考材料和标准操作程序(SOP)该办公室与UCCCC密切互动 信息技术小组、议定书审查和监测系统以及内部审查委员会。2016年，CCTO 开放152个新方案(24%是研究人员发起的)；总共有914名患者参加了 有19%的少数族裔(13%的非裔美国人)和48%的女性进行了治疗试验；3286名患者正在接受治疗 非干预性试验，49%的少数民族(46%的非裔美国人)和56%的女性。超过当前的拨款 周期，我们精简和加强了我们的审计方案，并采取了一系列努力，以增加 对试验的收益包括：对转诊医生的电子新闻广播，重新格式化面向公众的临床试验列表 UCCCC网站，开发新的教育和培训材料，以及建立临床 在我们不断发展的异地网络分支机构中试验基础设施。在未来五年，我们计划继续 这一轨迹将改善和提高服务效率，并根据需要开发新的服务。主修 芝加哥医科大学的战略举措，如增加我们的整合到网络，以及 由于我们的非现场地点网络将需要继续扩展和完善我们的临床研究 基础设施包括：a)扩大网络站点的临床试验准入和功能；b)继续 制定和实施增加患者收益的战略；以及c)在现有基础上 通过培训和联合SOP与部门研究人员(例如数据管理员和护士)整合。

ABSTRACT A critical component of the mission of the University of Chicago Medicine Comprehensive Cancer Center (UCCCC) is to offer patients the best and most personalized treatments available. The overall goal of the Clinical Protocol and Data Management (CDPM) is to establish and maintain the resources and processes to centralize and integrate the multidisciplinary component, and multidepartmental activities required to run and oversee a broad portfolio of clinical trials, including national cooperative group trials, other NCI/CTEP- sponsored trials and investigator-initiated trials developed through members’ translational research. An overarching theme is to ensure adequate enrollment of women, minorities, and children on our studies. The backbone of these operations is the Cancer Clinical Trials Office (CCTO), which is responsible for a) regulatory management for all adult cancer clinical trials, b) protocol tracking and management through a centralized Clinical Trials Management System (Velos eResearch); c) affiliate institution coordination and oversight, including 7 National Clinical Trials Network (NCTN) and Personalized Cancer Care Consortium affiliate networks, as well as over 40 additional ad hoc institutions; and d) quality control through centralized education and training, and formalized data and safety monitoring. We have well-established guidelines and a training manual for orientation of new regulatory managers as well as a centralized website with training videos, reference materials and Standard Operating Procedures (SOPs). The Office interacts closely with the UCCCC Information Technology Group, the Protocol Review and Monitoring System and the IRB. In 2016, the CCTO opened 152 new protocols (24% were investigator-initiated); a total of 914 patients were enrolled on therapeutic trials with 19% being minority (13% African American) and 48% women; 3286 patients were on non-interventional trials, with 49% minority (46% African American) and 56% women. Over the current grant cycle, we have streamlined and strengthened our audit program and instituted a number of efforts to increase accrual to trials including: e-newsblast to referring physicians, reformatting public-facing clinical trials listing on the UCCCC website, and development of new education and training materials, as well as building clinical trials infrastructure in our growing off-site network affiliates. Over the next five years, we plan to continue on this trajectory of improved and more efficient service, as well as to develop new services as needed. Major University of Chicago Medicine strategic initiatives, such as the additions to our integrated to network, as well as our network of off-site locations will necessitate continued expansion and refinement of our clinical research infrastructure including: a) Expansion of clinical trial access and functionality at network sites; b) Continued development and implementation of strategies to increase patient accrual; and c) Building on existing integration with Departmental research staff (e.g., data managers and nurses) through training and joint SOPs.