An Intelligent System for Clinical Trials

描述（由申请人提供）： 该提案的主要目标是开发一种创新的最先进的智能系统，用于管理精神健康临床试验。该系统旨在大大提高可用性，减少错误和成本，同时支持精神病学和行为研究的进步。在高度可扩展的体系结构的背景下，创新技术被引入（1）人机交互（HCI）设计方法学，通过应用基于认知理论的分析技术来定义交互模式;（2）一个多-一种机器用户交互算法，它使用一个公共的底层表单结构和智能，使系统的不同用户能够通过多种接口设备，如Web瘦客户机、移动的和台式计算机、手持计算机和个人数字助理（PDA），以及交互式语音应答（IVR）工具;以及（3）用于复杂心理测量仪器和详细临床试验协议建模的复杂智能数据表示的紧密集成。拟议的系统专门设计用于与试验研究者和开发人员、临床人员和患者有效互动，以提供高效的端到端试验数据采集、管理和分析，并集成了用于方案和表格设计的高级图形配置和可视化工具、自动化决策支持、合规性和不良事件跟踪、与外部系统的自主数据交换和警报机制。 在整个项目中，INFOTECH Soft将依靠其以用户为中心的成型设计过程和质量保证策略，以确保心理试验系统符合其功能要求，并让最终用户参与重要的可用性分析。在第一阶段，将对受试者预计使用PDA和基于Web的界面完成的一组严格定义的活动进行认知维度分析。该分析将导致定义每个设备特定的交互模式。将开发多机用户交互算法的原型，作为概念验证，以评估该技术的可行性和临床可接受性，并确定第二阶段开发需要解决的技术问题。在第二阶段结束时，心理试验系统将在临床试验中的各种现实条件下进行试点测试，以确保该系统符合功能规范，可用性要求和现实世界临床环境中的性能需求。

DESCRIPTION (provided by applicant): The main objective of this proposal is to develop an innovative state-of-the-art intelligent system for managing mental health clinical trials. This system is designed to greatly improve usability and reduce errors and costs, while enabling and supporting the advancement of psychiatric and behavioral research. In the context of a highly scalable architecture, innovative techniques are introduced for(1) a human-computer interaction (HCI) design methodology to define interaction patterns by applying analysis techniques solidly grounded on cognitive theory; (2) a multi-machine user interaction algorithm that uses a common underlying form structure and intelligence to enable the collection of data by different users of the system through a diversity of interface devices, such as Web thin clients, mobile and desktop computers, handheld computers and personal digital assistants (PDAs), and interactive voice response (IVR) tools; and (3) the tight integration of sophisticated, intelligent data representations for complex psychometric instruments and detailed clinical trial protocol modeling. The proposed system is specifically designed to effectively interact with trial investigators and developers, clinical personnel, and patients in order to provide efficient end-to-end trial data acquisition, management, and analysis, and incorporates advanced graphical configuration and visualization tools for protocol and form design, automated decision-support, compliance and adverse event tracking, autonomous data exchange with external systems, and alerting mechanisms. Throughout the project, INFOTECH Soft will rely on its user-centered formative design process and quality assurance strategy to ensure that the Psych Trials System adheres to its functional requirements and involves the end-user in important usability analysis. During phase I, cognitive dimensions analysis will be undertaken for a tightly defined set of activities that subjects are expected to accomplish using PDA and Web-based interfaces. This analysis will result in the definition of interaction patterns specific to each device. A prototype of the multi-machine user interaction algorithm will be developed as a proof-of-concept to assess the viability and clinical acceptance of the technique and to identify technical issues to be resolved towards phase II development. At the end of Phase II, the Psych Trials System will be pilot tested under a diverse set of realistic conditions in clinical trials to ensure that the system meets the functional specification, usability requirements, and performance demands in real-world clinical environments.