COMPUTERIZED CLINICAL TRIAL DATA ACQUISITION & ANALYSIS

计算机化临床试验数据采集

• 批准号: 3493045
• 负责人: ROBERT TINKELMAN
• 金额: $ 4.8万
• 依托单位: CAMBRIDGE COMPUTER ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-07-02 至 1993-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3493045
• 关键词: automated data processing; computer human interaction; computer program /software; computer system design /evaluation; data collection methodology /evaluation; information systems; interview; personal computers; statistics /biometry; telecommunications

New medications and medical procedures must undergo clinical trials before they can be certified by the FDA. The gathering and processing of trial data, as well as the general administration of the clinical process, can be both time-consuming and error-prone. Our goal is to reduce the time and administrative burden placed on researchers, freeing them for additional research, by providing them with a computerized method of tracking and reporting these data consistently. In this SBIR, Cambridge Computer Associates, Inc., and its research affiliate, BioSurface Technology, Inc. propose to develop a PC-based, user-friendly software system that allows individual researchers to customize CRF's collect data automatically (via telecommunications) from trials sites, and perform validity checking, statistical analysis, and reporting. Existing systems are expensive, often deviate from evolving industry standards, and provide incomplete solutions. The Phase I effort will define features and functions of the final system, identify appropriate existing software packages to integrate as components, specify new software, and prepare an initial prototype.

新药和医疗程序必须经过临床试验 才能通过FDA的认证。采集和处理 试验数据，以及临床的一般管理 过程，可能既耗时又容易出错。我们的目标是 减少研究人员的时间和管理负担，将 通过为他们提供计算机化的 持续跟踪和报告这些数据的方法。 在这个SBIR中，剑桥计算机协会公司及其研究 联营公司BioSurface Technology，Inc.提议开发一种基于PC的、 用户友好的软件系统，允许个人研究人员 定制CRF的自动收集数据(通过电信) 试验地点，并执行有效性检查、统计分析和 报道。 现有系统价格昂贵，往往偏离不断发展的行业 标准，并提供不完整的解决方案。 第一阶段的工作将定义最终版本的特点和功能 系统，确定适当的现有软件包作为集成 组件，指定新软件，并准备初始原型。