Clinical Protocol and Data Management

临床方案和数据管理：项目总结 临床试验核心（CTC）的使命是支持SCC成员开发和实施 最高质量的临床研究，为他们提供有效，高效和经济的 专门从事癌症研究的团队这使得协调强大的发电机启动， 试验（IIT），创新的行业赞助的试验，并积极参与合作团体和财团。的 CTC在方案制定、科学审查、法规提交、研究 协调、数据收集、教育、培训、财务管理和质量保证。反恐委员会 在项目期间持续增长，工作人员增加了52%（256名工作人员 今天）。这是由于临床试验累积相应增加所致。当比较五年 从当前项目周期到上一个项目周期的平均值，干预性临床试验应计费用 增加77%，而介入治疗临床试验收益增加25%。也有30%的 增加新的儿科临床试验的激活，这是CTC内增长的目标领域。项目成长 包括在整个项目中由方案开发部门管理的新IIT提交量增加52% 期CTC一直在寻求机会，以缩短所有试验类型的方案启动时间， 商业IRB将行业申办试验的IRB批准时间缩短38%，并允许行政管理 已在另一个机构获得科学审查委员会批准的机构试验的科学审查 NCI癌症中心减少了14天。此外，反恐委员会采用技术报告关键 性能指标，并使调查人员能够获得与其项目相关的实时数据。2015年，CTC 启动OnCore临床试验管理系统（CTMS），便于向PRMS提交， 作为已获得监管批准的文件的基于网络的存储库， 研究者和统计学家可随时访问的机构临床试验数据采集系统， 关键指标，包括在流程改进项目中经常使用的基于协议和应计的数据。的 OnCore CTMS的实施为增强临床试验的实时监测提供了机会 纳入少数民族，农村和医疗服务不足的患者的应计费用，以及2018年SCC的整体患者 人群包括15.5%的少数民族患者，但有28.1%的少数民族患者参与了干预性试验。

CLINICAL PROTOCOL AND DATA MANAGEMENT: PROJECT SUMMARY The mission of the Clinical Trials Core (CTC) is to support SCC members in the development and conduct of clinical research of the highest quality by providing them with access to an effective, efficient and economical team specializing exclusively in cancer research. This allows for the coordination of robust investigator-initiated trials (IIT), innovative industry-sponsored trials, and active participation in cooperative groups and consortia. The CTC offers comprehensive services in protocol development, scientific review, regulatory submission, study coordination, data collection, education, training, financial management, and quality assurance. The CTC has experienced continued growth during the project period, with a staffing increase of 52% (256 staff members today). This resulted from a corresponding increase in clinical trial accrual. When comparing the five-year average from the current project period to the previous project period, interventional clinical trial accrual increased 77% while interventional treatment clinical trial accrual increased 25%. There has also been a 30% increase in activation of new pediatric clinical trials, a targeted area for growth within the CTC. Project growth includes a 52% increase in the submission of new IITs managed by Protocol Development across the project period. The CTC has pursued opportunities to reduce protocol activation timelines across all trial types, utilizing commercial IRBs to reduce IRB approval time by 38% for industry-sponsored trials and by allowing administrative scientific review for institutional trials that have already received scientific review committee approval at another NCI cancer center resulting in a reduction of 14 days. In addition, the CTC employs technology to report key performance metrics and empower investigators with real-time data related to their projects. In 2015, the CTC launched the OnCore Clinical Trial Management System (CTMS), which facilitates submission to the PRMS, serves as a web-based repository for documents that have received regulatory approval, houses an electronic data capture system for institutional clinical trials readily accessible by investigators and statisticians, and tracks key metrics including protocol- and accrual-based data regularly utilized in process improvement projects. The implementation of the OnCore CTMS provided opportunities for enhanced real-time monitoring of clinical trial accrual for inclusion of minority, rural, and medically underserved patients, and in 2018, SCC’s overall patient population included 15.5% minority patients but boasted 28.1% minority accrual to interventional trials.