VOICE RESPONSE/INTERNET REGISTRATION AND RANDOM SYSTEM

大多数评估治疗对生物体影响的实验都涉及比较接受治疗的一组个体和未接受治疗（或接受替代治疗）的一组个体的反应。在这类研究中经常需要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的、用户友好的访问，以获得专业质量、可审计的登记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，适应双盲、单盲和非盲设计，并允许研究设计的灵活性。它将支持多个用户同时访问，同时管理多项研究，并在用户界面中支持多种语言。它将支持通过按键式电话、或从任何可接入互联网和标准网络浏览器的个人电脑、或通过交换电话网络的拨号调制解调器进行访问。所有模块都将经过正式确认，以确保符合FDA对软件确认的要求。这笔赠款的目的是最后确定系统要求;设计系统的架构;开发功能规格;开发置换块随机化算法的原型;开发电话和网络用户界面的原型;并使用原型来展示系统的可行性和优点。拟议的商业应用：根据这项拨款开发的软件将允许制药公司，NIH赠款接受者，大学和其他进行随机实验的公司使用电话和基于Web的用户界面快速，廉价地创建用于患者登记和随机化的专业质量计算机系统。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，每年仅人类医学研究就超过9,000例）。

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).