Clinical Protocol and Data Management

摘要 芝加哥大学医学综合癌症中心使命的关键组成部分 （UCCCC）是为患者提供最好的和最个性化的治疗。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， 集中和整合多学科组成部分，以及运行和 监督广泛的临床试验组合，包括国家合作组试验，其他NCI/CTEP- 赞助的试验和通过成员的转化研究开发的制药商发起的试验。一个 首要的主题是确保妇女，少数民族和儿童在我们的研究足够的招生。的 这些操作的骨干是癌症临床试验办公室（CTO），负责a）监管 B）通过集中的管理系统进行方案跟踪和管理， 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多个特设机构; 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 新的监管管理人员概况介绍手册以及一个提供培训视频的集中网站， 参考材料和标准操作规程（SOP）。该办公室与UCCCC密切互动 信息技术组、方案审查和监测系统以及IRB。2016年，CCTO 开放了152个新方案（24%为透析器启动）;共有914例患者入组 治疗试验，19%为少数民族（13%为非洲裔美国人），48%为女性; 3286例患者接受了 非干预性试验，49%为少数民族（46%为非洲裔美国人），56%为女性。在目前的赠款 在审计周期内，我们精简和加强了审计计划，并采取了一系列措施， 增加试验费用，包括：向转诊医生提供电子新闻快讯，重新格式化面向公众的临床试验清单， UCCCC网站，开发新的教育和培训材料，以及建立临床 在我们不断增长的非现场网络附属机构的试验基础设施。在未来五年，我们计划继续 这一轨道的改进和更有效的服务，以及开发新的服务需要。主要 芝加哥大学医学院的战略举措，如增加我们的综合网络，以及 由于我们的非现场位置网络将需要继续扩大和完善我们的临床研究 基础设施，包括：a）扩大临床试验的访问和网络站点的功能; B）继续 制定和实施战略，以增加病人的增加;和c）在现有的基础上 与部门研究人员的整合（例如，数据管理人员和护士）通过培训和联合SOP。

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.