临床试验北京大学临床药理研究所 侯芳 目录II 期临床试验前应考虑的伦理原则...............................................................................................1我国 GCP 规定临床试验方案内容.................................................................................................2临床试验设计(design of clinical trial)...........................................................................................2新药临床试验为什么必须设对照组？...........................................................................................3对照药的选择..................................................................................................................................3安慰剂(placebo)...............................................................................................................................41. 安慰剂效应(placebo effect).................................................................................................42. 安慰剂在药物评价中的作用...............................................................................................4使用安慰剂对照的注意事项...................................................................................................4临床研究病例数的估计..................................................................................................................4对照试验类型..................................................................................................................................5随机化（Randomization)...............................................................................................................5盲法试验（Blind Trial Technique）.............................................................................................6盲法试验准备工作..................................................................................................................6病人的依从性（Patient compliance)...........................................................................
