多中心临床试验中的中央随机系统研究

Central randomization system in multi-center clinical trials

目的:加强多中心临床试验管理,提高试验效率,缩短试验周期,减少药物浪费,保障试验质量。方法:利用计算机电话集成(computer telephone integration,CTI)技术,将计算机、电信和网络技术进行集成,成功研发出多中心临床试验中央随机系统并应用于临床试验。结果:多中心临床试验中央随机系统实现了受试者筛选、随机化、药物发放和药物供应链管理等功能。结论:多中心临床试验中央随机系统对跨地域多中心临床试验管理非常有意义。

AIM： To enhance management and efficiency of clinical trials, reduce the clinical trial cycle, waste drug, and insure the quality of trials. METHODS： The computer telephone integration （CTI） technology to integrate computer, internet and telecom was adopted. Finally by the technology, the Central Randomization System was successfully developed and applied to some clinical trails. RESULTS： The Central Randomization System could be used to screening subjects, dispensing drugs, and administrating the drug sup- ply chain. CONCLUSION： The Central Randomization System can efficiently administrate the multi-central clinical trails acrossing many areas or even over many countries.