基于互联网的临床试验模式

A Clinical Trial Model Based on Internet Platform

目的针对目前医学临床试验(特别是非盲试验)中存在的各种偏倚和质量问题,建立基于技术手段的解决方法。方法提出基于互联网平台的临床试验模式,将以往所有试验环节和工作人员均面向课题负责人的模式转变成为面向统一的互联网工作平台的新模式,通过互联网平台连接和实现临床试验的主要环节,并自动实时记录所有操作过程,实现远程数据共享。结果这种模式使试验的诸多环节成为可核查、可客观分析评价质量、可多方独立参与的过程,并提高了大型多中心临床试验的工作效率和管理水平。结论这种模式的数据采集过程分析和数据质量分析功能可以较严格地控制各种人为偏倚和学术不端行为。

Objective To ensure the reliable and high quality clinical trials （especially non-blind trial）. Methods A clinical trial model based on internet platform is proposed. The concept of the new model is to change the responsibilities from all the test courses and trial staff for principle investigators to a unique internet platform. This model realizes remote data sharing by connecting internet platforms, carrying out the main courses of clinical trials, and recording all tile real-time operating process automatically. Result This model makes the trial process more verifiable, objective, and independent, and helps to establish a standard of management for large muhi-center clinical trials. Conclusions The internet platform model is advanced in controlling various contrived bias and academic misconduct much more strictly, in data collection process and analysis of the clinical trials.