临床试验中心随机化网络系统实现和测试

Implementation and testing of randomized network system in clinical trial center

目的:研制基于网络平台的中心随机化分组系统,并在临床试验进行测试。方法:以Pocock-Simon最小随机化方法为理论依据,采用MVC设计模式,利用JAVA编程语言实现本系统,并采用4个临床试验进行测试。结果:经统计学检验,各个终点指标的组间均衡性很好,P>0.05。结论:本研究能够高效实现不同组数的病人随机化分配。

Objective: To design on Central Randomization Allocation System with Web-support and JAVA and test this system in four clinical trials. Methods: This system is designed by Pocock- Simon's minimization random algorithms. The MVC module,JAVA programming language and other technologies are also applied to achieve this system. Four clinical trials were designed to test this system. Results: After test of significance, the indexes were successfully balanced among different treatment groups, P>0.05.Conclusion: This study provided a sophisticated system for supporting random allocation of patients to arbitrary number of treatment groups.