Development of Distributed Electronic Clinical Trials

描述(由申请人提供)：今天，超过80%的临床试验仍然使用纸质表格进行数据收集。将数据从纸质来源文件转录到中央数据库的成本很高，也是临床试验中的另一个错误来源。随着互联网和低成本个人计算机的出现，定制软件已经开发出来用于 临床试验，极大地提高了数据的准确性，并缩短了完成临床试验的平均时间。这些应用程序的主要问题是开发定制软件的巨额费用。这笔费用，再加上许多临床站点运行各种操作系统和实践管理软件，证明是当前临床试验软件的主要缺点。 在这项提案中，Infotech Soft将开发一个集成的临床试验开发和分布式管理框架，以降低创建和管理临床试验的成本并提高效率。拟议系统解决的主要技术问题是通过使用互联网和手持设备实现管理环境的可移植性 移动设备，通过使用开放的XML标准实现临床表格和临床数据的可移植性，临床研究人员快速创建和管理电子临床试验的能力，以及该系统与现有信息系统集成的能力。因此，与目前的纸质和计算机化技术相比，该系统本质上更好、更复杂。Infotech软件解决方案包括四个主要组件：临床试验开发者、临床试验管理员、临床试验数据库和系统集成。该系统利用互联网和手持移动设备来提供临床试验数据的轻松协调。 拟议的商业应用：该系统能够创建定制的灵活的电子临床表格，这在临床试验中尤其重要，因为在临床试验中，需要评估需要定制的临床表格的新的和实验程序。支持互联网和移动手持设备。纳入用于存储和检索主题数据的临床研究数据库以及利用开放数据交换协议是在临床试验中共享和交换信息的基本特征。

Description (provided by applicant): Today over 80 percent of clinical trials are still conducted utilizing paper forms for data collection. Transcription of data from paper source documents to a central database is expensive and an additional source of error in clinical trials. With the advent of the Internet and low-cost personal computers, custom software has been developed for clinical trials, dramatically increasing data accuracy and reducing the average time it takes to complete a clinical trial. The major problem with these applications is the large expense to develop custom software. This expense combined with the fact that many clinical sites are running various operating systems and practice management software prove to be major drawbacks to current clinical trial software. In this proposal, INFOTECH Soft will develop an integrated clinical trial development and distributed administration framework to reduce the cost and increase the efficiency of creating and administering clinical trials. The major technical issues addressed by the proposed system are the portability of the administration environment through the use of the Internet and handheld mobile devices, the portability of clinical forms and clinical data through the use of open XML standards, the ability of clinical investigators to quickly create and manage electronic clinical trials, and the ability of the system to be integrated with existing information systems. As a result, the system is inherently better and more sophisticated compared to current paper-based and computerized techniques. The INFOTECH Soft solution includes four major components, the Clinical Trial Developer, Clinical Trial Administrator, Clinical Trial Database, and Systems Integration. The system utilizes the Internet and handheld mobile devices to provide easy coordination of clinical trial data. PROPOSED COMMERCIAL APPLICATION: The system enables the creation of customized flexible electronic clinical forms, which is especially important in clinical trials where new and experimental procedures, requiring custom-built clinical forms, are evaluated. Support for Internet and mobile handheld devices. Incorporation of a clinical study database for storage and retrieval of subject data along with the utilization of open data interchange protocols are essential features for sharing and exchanging information in clinical trials.