最小化随机分组系统支持多治疗组分组的方法设计

A random allocation system with minimization designing for web-supported multi-treatment-allocation groups

目的:使最小化随机分组系统支持多治疗组分组。方法:以Pocoek and Simon最小化随机化法作为分组的理论基础,使用面向对象的数据库设计方法,以ASP(Active Server Pages)编程实现。结果:该方法理论上支持包含任意个数治疗组的临床试验使用最小化随机分组算法进行分组。设计一个包含3因素8水平的临床试验,模拟60个病例数据并将其分别分为3组和4组,分组结果在治疗组间均衡,而且不需要额外编写程序。结论:该方法使最小化随机分组系统可以应用在多治疗组或者两个治疗组中包含不等比例病例数的临床试验中。

Objective： To develop a random allocation system with minimization method used to perform precise and rapid treatment assignments in multi-treatment groups. Methods： This system is designed to run on a generic database schema according to Pocock and Simon＇s minimization random method and active server pages （ASP） programming technique. Results： This study provided a sophisticated system for supporting random allocation of patients to arbitrary number of treatment groups. The randomized treatment assignments with this system was successfully to balance patients＇ numbers for eight levels of three prognostic factors over an entire trial and at the same time balance the allocation of 60 simulating patients data within 3 and 4 treatment groups. This system was being used effectively in assignments of treatment groups of sequential randomized clinical trials without further programming in China. Conclu- sion： This system has the potential to make m：n ratio of patients minimized in the randomized multior two-treatment arms of clinical trials.