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.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2009年第8期637-640,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
临床试验
随机分配
统计学
SAS程序
clinical trails
random allocation
statistics
SAS program
