基于网络的随机化系统在临床试验中的应用及其评价

Application and evaluation of Interactive Web of Randomization System in drug clinical trials

多中心临床试验随机化的准确实施直接影响临床试验质量,基于网络的随机系统(IWRS)通过计算机、网络技术及手机通讯功能的集成,可以实现随机化分配、药品管理、应急信件管理等功能。尤其是与手机通讯功能的集成,使系统应用不再受限于网络,大大提高了系统的实用性。随机化系统的应用可提高随机化实施的准确程度,降低偏倚,减少药品浪费,简化管理环节,节约研究成本,对提高临床试验效率和临床试验质量都具有实际意义。

The performance of randomization directly influences the quality of multicenter clinical trials.The new tool,the Interactive Web of Randomization System（IWRS） based on internet can provide a lot of functions,such as randomization assignment,test drug management,service of short message from cellphone and emergency letter.Especially,the integration with cellphone communication function makes the system break the limitation of web network,and improves the practice of the system.The application of IWRS can improve the accuracy of randomization,decrease the bias,reduce drug losing,simplify administration link,and save research cost in quality control of clinical trials.