多适应证、多中心临床试验随机化方案及SAS程序  

Randomized protocol and SAS program of multi-center clinical trials for many indications

作　　者：李雪峰[1] 吴艳乔[2] 周小轲[1] 陈春蓉[1] 

机构地区：[1]四川大学华西公共卫生学院卫生统计学教研室,四川成都610041 [2]四川大学华西第二医院信息管理部,四川成都610041

出　　处：《中国新药与临床杂志》2009年第8期637-640,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：主要介绍多适应证、多中心且各中心分配例数不等的临床试验随机化方案的设计。设计规程包括随机化参数设定、随机化规定、SAS随机程序设计,以及由此产生的适应证随机编码、试验中心随机编码、试验病例随机编码、处理组的随机编码和试验药物包装表。A design was introduced in this article for randomized protocol of multi-center clinical trial, which dealed with many indications and unequally distributed cases in centers. The design procedure included presetting randomized parameters, stipulating randomized rules, writing SAS program and forming these randomized codes for indications, cases, treated groups as well as developing packaging form of medicine.

关 键 词：临床试验 随机分配 统计学 SAS程序 

分 类 号：R969.4[医药卫生—药理学]