Kelly M A, Oldham J
Centre for Health Services Research, University of Leeds, UK.
Int J Med Inform. 1997 Nov;47(1-2):91-9. doi: 10.1016/s1386-5056(97)00091-9.
Several factors constrain the implementation of Randomised Controlled Trials (RCTs). To obtain large sample sizes a multicentred multinational trial may be necessary or a long sampling period. The larger the trial the larger is the unit cost. To allow larger sample sizes, shorter sampling periods and lower unit costs, new methods are needed. The Internet and in particular the WWW provides such an opportunity. The WWW can provide global access, fast interaction and automation. A prototype Internet Trials Service (ITS) is currently being tested with a real international clinical trial (the Growth Restriction Intervention Trial--GRIT). The ITS is hosted on a Web server. It provides a series of HTML documents that describe the GRIT protocol. Registered centres may enter patients into the GRIT trial via ITS. Java applets are used to collect trial data before returning the study number and randomisation. ITS assumes all trial data will be intercepted by a sniffer. Therefore no information is sent that could specifically identify a patient, this must be sent later by more secure means. ITS assumes that trial centres can be spoofed. To authenticate the patients entered into the trial and the trial data sent, a regular audit report is sent to each centre by secure means for confirmation. By using Java, a full functional data entry system can be developed that runs locally within any Java enabled browser. It can perform data validation locally and also provide a sophisticated user interface.
有几个因素限制了随机对照试验（RCT）的实施。为了获得大样本量，可能需要进行多中心跨国试验或延长抽样周期。试验规模越大，单位成本就越高。为了实现更大的样本量、更短的抽样周期和更低的单位成本，需要新的方法。互联网，尤其是万维网（WWW）提供了这样一个机会。万维网可以提供全球访问、快速交互和自动化。一个互联网试验服务（ITS）原型目前正在与一项实际的国际临床试验（生长受限干预试验——GRIT）一起进行测试。ITS托管在一个网络服务器上。它提供了一系列描述GRIT方案的HTML文档。注册中心可以通过ITS将患者纳入GRIT试验。Java小程序用于在返回研究编号和随机分组之前收集试验数据。ITS假定所有试验数据都会被嗅探器拦截。因此，不会发送能够具体识别患者的信息，这些信息必须稍后通过更安全的方式发送。ITS假定试验中心可能会被欺骗。为了对纳入试验的患者和发送的试验数据进行认证，会通过安全方式向每个中心发送一份定期审核报告以供确认。通过使用Java，可以开发一个全功能的数据输入系统，该系统可以在任何支持Java的浏览器中本地运行。它可以在本地进行数据验证，并提供一个复杂的用户界面。
