What can improve physician and patient access to NCI-sponsored clinical trials?

挑战

在不断变化的医疗保健和财政环境中，新疗法和新技术的迅速增加促使美国国家癌症研究所(NCI)于1999年成立了癌症试验支持单位(CTSU)，以简化和协调多中心的支持服务, 大规模的, phase 3 cancer clinical trials across the country.

具体地说, CTSU集中收集场址管理和名册数据的初步启动为场址访问协议和协议文件提供了一个中央网站，并促进了跨组登记. 这导致了效率的提高，合格的研究人员和临床地点更容易进入nci资助的临床试验, thereby increasing patient access to clinical trials close to their homes.

这些活动需要具备操作和IT开发能力的团队成员, systems security expertise, a commitment to quality assurance, a talent for creative solutions, plus the flexibility to change direction to meet new needs. NCI contracted with 趣赢平台 in 1999 to help run the CTSU. We have retained this work ever since.

解决方案

Since 1999, the CTSU has continued to provide innovative solutions. Critical to clinical trial success is the enrollment of patients, 以及趣赢平台开发和维护肿瘤患者登记网络(OPEN)系统, clinical sites in the U.S. and internationally can enroll patients in clinical trials 24 hours a day. OPEN integrates with protocol, 名单, 监管数据，以确保合格的网站注册研究，并与外部系统集成，以支持数据收集和报告. Our software engineering services drive the development, 实现, and project integration for multiple collaborative systems. Our CTSU IT system incorporates industry-standard best practices, 过程改进, 并通过完成ISACA的能力成熟度模型集成(CMMI)开发(DEV)在第3级的评估来关闭能力差距.

数据协调

趣赢平台 synchronizes the 实现 of a common clinical data management system (CDMS), Medidata狂欢, across NCI’s Cancer Therapy Evaluation Program (CTEP) system. Through data harmonization, 我们整合了跨站点的异构数据库，以便癌症临床试验参与者的数据可以协调和汇集. These data are then available for analyses based on a common standard.

工具

To streamline and automate clinical trial data processing, 提高产品质量, and support regulatory submission, we employ CDISC standards (CDASH, 澳门旅游娱乐有限公司, 和亚当). 除了, 趣赢平台使用交互式数据可视化技术根据关键性能指标监控站点性能, document audit performance, and produce camera-ready graphics for publication. These techniques improve not only trial efficiency but also participant safety.

Supporting Infrastructure

To support CTSU activities, 已开发企业Oracle数据库，并与客户端的企业Oracle数据库集成，为项目网站和应用程序提供后端支持. 这个基础设施已经扩展为通过高级XML消息传递技术和web服务提供与其他研究组织的实时信息交换. 全面的CTSU网站包括积极的CTSU支持的临床试验方案清单, displays of accrual information, and links to study abstracts facilitating investigator and research staff participation. CTSU的应用程序套件运行在不同的平台上，并托管在趣赢平台的数据中心. Business continuity is ensured by having multiple levels of redundancy.

Clinical Site Support Tasks

Other supportive activities include providing robust educational resources on the CTSU website; helping sites organize study activities, including creating National Coverage Analysis (NCA) templates and Electronic Medical Record (EMR) setup templates; operating a helpdesk for clinical trial researchers and staff support; and developing and maintaining a comprehensive clinical trials systems infrastructure, which provides real-time data exchange with collaborating organizations. 我们通过西方国家开发的数据质量门户(DQP)和绩效评估网站评分(PASS)应用程序收集数据质量指标，支持临床现场绩效管理, 并通过提供西方开发的源文档门户(SDP)来上传源文档，从而支持远程监控和现场审计.

另外, 我们将服务扩展到nci赞助的临床试验例如国家临床试验网络(NCTN), the Experimental Therapeutics 临床试验 Network (ETCTN), and the Community Oncology Research Program (NCORP), as well as other programs.

结果

我们在CTSU的运作使临床试验面向更广泛的研究人员，并为500多个试验和500个入组提供了基础设施,000+ patients since its inception in 1999. The clinical trials we have supported have led to the development of lifesaving treatments, 新型诊断工具, and better medical devices benefiting millions of cancer patients in the U.S. 在世界范围内.

来自CTSU的数据示例包括分配个性化治疗方案的试验(Rx)或TAILORx试验, 哪项研究表明化疗对70%最常见类型的乳腺癌患者没有任何益处，并为这些患者提供了更好或更有效的治疗方案. 也, operating groundbreaking precision medicine trials, 比如MATCH, the Exceptional Responders trial, 和LUNG-MAP, have deepened researchers’ understanding of cancer treatments.

CTSU是NCI支持拜登政府癌症登月计划的一个组成部分. 趣赢平台将协调临床试验方案的实施并提供监管支持服务, providing 24/7 operational support to the entire lifecycle of these clinical trials.