WORLD WIDE WEB TOOLS FOR COLLABORATIVE CLINICAL TRIALS

万维网和相关互联网技术的出现 为收藏提供了范式转变的可能性，并 管理多点临床试验的临床研究数据。 这一新的范式的特点是 中央协调站点和协作中心， 承诺在成本效益领域带来重要的好处， 及时性、数据质量和患者安全性的增强。 在实现这些好处之前，数据管理流程使用 今天，要支持大型试验，必须重新设计，以利用 互联网技术。在第一阶段，我们将讨论几个关键设计 领域：(L)数据库的快速生成和基于浏览器的关联 用于新临床研究的CRF页面，(2)数据安全和访问 控制，(3)有适当检查和帮助的生产数据录入 设施，以及(4)协作解决数据差异和 有关不良事件的信息。在每一个领域，我们都会 原型和评估一项或多项特定技术，利用 来自现有多中心试验的信息。在第二阶段，我们会 与临床试验研究组织协作创建和 测试基于Internet的临床数据管理的完整原型 系统。 建议的商业应用：我们预计在 这个项目将导致软件工具可以销售到 制药公司和其他从事临床工作的研究团体 审判。贝尔蒙研究公司在设计方面拥有丰富的经验， 支持临床的计算机软件的开发和营销 试验数据的收集和分析过程。

The emergence of the World Wide Web and related Internet technologies offers the potential of a shift in the paradigm for the collection and management of clinical research data for multi-site clinical trials. This new paradigm is characterized by a much closer interaction between the central coordinating site and the collaborating centers, which promises important benefits in the areas of cost-effectiveness, timeliness, data quality, and enhancement of patient safety. Before these benefits can be realized, the data management process used today to support large trials must be reengineered to take advantage of Internet technology. In Phase I, we will address several critical design areas: (l) rapid generation of databases and associated browser-based CRF pages for new clinical studies, (2) data security and access control, (3) production data entry with appropriate checking and help facilities, and (4) collaborative resolution of data discrepancies and information about adverse events. In each of these areas, we will prototype and evaluate one or more specific techniques utilizing information from an existing multi-center trial. In Phase II, we will collaborate with a clinical trials research organization to create and test a full prototype of an Internet-based clinical data management system. PROPOSED COMMERCIAL APPLICATION: We expect the technology developed in this project to lead to software tools which can be marketed to pharmaceutical companies and other research groups that perform clinical trials. Belmont Research has extensive experience in the design, development and marketing of computer software to support the clinical trials data collection and analysis process.