VOICE RESPONSE/INTERNET REGISTRATION AND RANDOM SYSTEM

语音应答/互联网注册和随机系统

• 批准号: 2869997
• 负责人: HERMAN E. MITCHELL
• 金额: $ 9.44万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-05-15 至 2000-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2869997
• 关键词: Internet; artificial intelligence; clinical trials; computer program /software; computer system design /evaluation; interactive multimedia; patient /disease registry; statistics /biometry; telecommunications

Most experiments evaluating the effect of treatments on living organisms involve comparison between the responses of a group of individuals given the treatment and those of a group not treated (or given an alternative treatment). A frequent requirement in such studies is random assignment of individuals to treatment groups. The goal of this project is to develop an Interactive Registration and Randomization System (IRRS) providing comprehensive randomization functions to researchers, targeted particularly to clinical trials, but also usable for other types of randomized experiments. The proposed product will provide cost-effective, user-friendly access to all of the functionality necessary for professional quality, auditable registration and randomization. It will support all of the randomization procedures currently in use, accommodate double-masked, single-masked, and unmasked designs, and allow flexibility in study design. It will support simultaneous access by multiple users, simultaneous management of multiple studies, and support for multiple languages in the user interface. It will support access by touch-tone phone, or from any PC with Internet access and a standard web browser, or by dial-up modem over the switched phone network. All modules will be formally validated to ensure compliance with FDA requirements for software validation. The aims of this grant are to finalize system requirements; design the architecture of the system; develop functional specifications; develop prototypes of the permuted block randomization algorithm; develop prototypes of the phone and web user interfaces; and use the prototypes to demonstrate the feasibility and merits of the system. PROPOSED COMMERCIAL APPLICATIONS: The software to be developed under this grant will permit pharmaceutical companies, NIH grant recipients, universities, and others conducting randomized experiments to quickly and inexpensively create professional- quality computer systems for patient registration and randomization, using both telephony and web-based user interfaces. The product will provide a cost-effective alternative to the "home-grown," single-use systems currently in use, offering significant savings for the thousands of randomized trials initiated each year (e.g., over 9,000 per year in human medical research alone).

大多数评估治疗对生物体影响的实验都涉及到在接受治疗的一组个体与未接受治疗（或接受替代治疗）的一组个体的反应之间进行比较。这类研究的一个常见要求是将个体随机分配到治疗组。该项目的目标是开发一个交互式注册和随机化系统（IRRS），为研究人员提供全面的随机化功能，特别是针对临床试验，但也可用于其他类型的随机化实验。拟议的产品将提供具有成本效益，用户友好的访问专业质量，可审计注册和随机化所需的所有功能。它将支持目前使用的所有随机化程序，适应双掩码、单掩码和非掩码设计，并允许研究设计的灵活性。它将支持多个用户同时访问，同时管理多个研究，并在用户界面中支持多种语言。它将支持通过按键式电话访问，或从任何具有互联网接入和标准网络浏览器的个人电脑访问，或通过交换电话网络的拨号调制解调器访问。所有模块将进行正式验证，以确保符合FDA对软件验证的要求。这笔赠款的目的是最后确定系统需求；设计系统的体系结构；制定功能规范；开发排列块随机化算法的原型；开发手机和网络用户界面的原型；并通过样机验证了系统的可行性和优点。拟议的商业应用：根据该拨款开发的软件将允许制药公司、NIH资助接受者、大学和其他进行随机实验的机构快速、廉价地创建专业质量的计算机系统，用于患者注册和随机化，使用电话和基于网络的用户界面。该产品将为目前使用的“国产”一次性系统提供一种具有成本效益的替代方案，为每年启动的数千项随机试验（例如，每年仅在人类医学研究中就有9000多项试验）提供可观的节省。