Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10379997
• 负责人: KATHLEEN H GOSS
• 金额: $ 37.14万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10379997
• 关键词: Adult; African American; Biostatistics Core; Cancer Center Support Grant; Cancer Therapy Evaluation Program; Caring; Catchment Area; Chicago; Child; Childhood; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Comprehensive Cancer Center; Core Facility; Data; Development; Diagnosis; Enrollment; Ensure; Five-Year Plans; Goals; Good Clinical Practice; Grant; Guidelines; Hospitals; Information Services; Information Technology; Infrastructure; Institutes; Institution; Institutional Review Boards; International; Investigational New Drug Application; Joints; Location; Malignant Neoplasms; Manuals; Medicine; Minority; Mission; Monitor; National Clinical Trials Network; Nurses; Patients; Physicians; Prevention; Procedures; Process; Program Development; Protocols documentation; Quality Control; Regulation; Research; Research Infrastructure; Research Personnel; Resources; Review Committee; Risk; Running; Safety; Services; Silver; Site; System; Therapeutic Trials; Training; Training and Education; Translational Research; Universities; Vertebral column; Woman; anticancer research; base; cancer clinical trial; clinical care; data management; demographics; ethnic difference; improved; innovation; investigator-initiated trial; member; minority children; multidisciplinary; operation; patient safety; personalized cancer care; personalized medicine; programs; racial difference; real time monitoring; screening; side effect; tool; treatment response; web site; website development

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.

抽象的 芝加哥大学医学综合癌症中心任务的关键组成部分 （UCCCC）是为患者提供最佳，最个性化的治疗方法。总体目标 临床协议和数据管理（CDPM）是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运行所需的多部门活动 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- 赞助的试验和研究人员发起的试验通过成员的翻译研究开发。一个 总体主题是确保在我们的学习中足够的妇女，少数民族和儿童入学。 这些操作的骨干是癌症临床试验办公室（CCTO），其负责a）监管 所有成人癌症临床试验的管理，b）通过集中的协议跟踪和管理 临床试验管理系统（Velos Eresearch）； c）会员机构协调和监督， 包括7个国家临床试验网络（NCTN）和个性化的癌症护理联盟 网络以及超过40多个临时机构； d）通过集中教育的质量控制 和培训，以及正式的数据和安全监控。我们有完善的准则和培训 新监管经理的导向以及带有培训视频的集中式网站的手册 参考材料和标准操作程序（SOP）。办公室与UCCCC紧密互动 信息技术小组，协议审查和监视系统以及IRB。 2016年，CCTO 开放了152种新方案（研究人员发起的24％）；总共招募了914名患者 治疗试验是少数族裔（13％的非裔美国人）和48％的女性； 3286例患者开始 非际交往试验，有49％的少数民族（46％的非裔美国人）和56％的妇女。超过当前赠款 循环，我们已经简化和加强了我们的审计计划，并提出了许多努力以增加 应计试验，包括：电子新闻与推荐医生，重新格式化公共面向公共的临床试验列表 UCCCC网站以及新的教育和培训材料的开发以及建造临床 在我们不断增长的现场网络分支机构中，试验基础设施。在接下来的五年中，我们计划继续 这项改进，更有效的服务以及根据需要开发新服务的轨迹。主要的 芝加哥大学医学战略计划，例如我们整合到网络的添加 由于我们的现场位置网络将需要扩展和完善我们的临床研究 基础架构包括：a）网络站点的临床试验访问和功能的扩展； b）继续 制定和实施提高患者准确性的策略； c）建立在现有的 通过培训和联合SOP与部门研究人员（例如数据经理和护士）集成。