Integrated and Distributed Electronic Clinical Trials

描述（由申请人提供）： 该提案的主要目标是通过开发一个创新的最先进的分布式电子临床试验管理系统沿着一套集成的临床试验开发工具来改善临床试验的开发和管理。所提出的系统有效地与临床试验开发者、临床研究者和进行临床试验的工作人员进行交互，并与外部数据源进行接口，以提供高效的端到端临床试验数据采集、管理和分析。临床试验开发工具的集成套件使临床研究人员能够通过图形用户界面轻松设计临床表格和试验方案，同时自动执行表格和方案表示、数据库创建和配置以及与外部数据源接口的任务。该提案建立在第一阶段在四个关键领域建立的技术可行性基础上：（1）使用开放式可扩展标记语言（XML）以电子方式表示临床试验方案、表格和数据;（2）设计一个基于网络的试验管理工具，其中包括决策支持逻辑，以生成处理不良事件的临床警报;以及（3）临床试验开发环境的体系结构，用于使得能够定义定制临床试验协议和表格;以及（4）开发一种新技术，用于自动生成临床试验数据库和参与临床试验的研究中心之间的相关同步方案。审判 所提出的系统的固有自动化，定制，便携性和可扩展性的特点建立其潜力的高效和有效的管理范围广泛的临床试验，涉及多个网站和不同的要求，复杂性和协议。在本提案的背景下，将通过与临床顾问的密切合作，对系统的临床可接受性和可用性进行评价和评估。

DESCRIPTION (provided by applicant): The main objective of this proposal is to improve the development and administration of clinical trials by developing an innovative state-of-the-art distributed electronic clinical trial management system along with an integrated suite of clinical trial development tools. The proposed system effectively interacts with clinical trial developers, clinical investigators, and staff conducting clinical trials, and interfaces with external data sources in order to provide efficient end-to-end clinical trial data acquisition, management, and analysis. The integrated suite of clinical trial development tools enables clinical investigators to easily design clinical forms and trial protocols through a graphical user interface, while automating the tasks of form and protocol representation, database creation and configuration, and interfacing with external data sources. The proposal builds upon the technical feasibility established during phase I in four key areas: (1) electronic representation of clinical trial protocols, forms, and data using the open extensible Markup Language (XML); (2) design of a web-based trial administration tool incorporating decision support logic to generate clinical alerts for handling adverse events; and (3) architecture of a clinical trial development environment for enabling the definition of custom clinical trial protocols and forms; and (4) development of a novel technique for automated generation of the clinical trial database and associated synchronization schemes among sites participating in a clinical trial. The inherent automation, customization, portability and scalability characteristics of the proposed system establish its potential for efficient and effective management of a wide range of clinical trials involving multiple sites and varying requirements, complexities, and protocols. In the context of this proposal, the system will be evaluated and assessed in terms of clinical acceptance and usability through close collaboration with clinical consultants.