新药临床试验最低例数规定的安全性评价

Lowest sample size and its safety in clinical trials in China

新药临床试验中 ,对于有效性分析 ,样本大小理应由统计学估算来决定 ;但从安全性角度 ,样本例数应有最低例数的规定。本文通过计算不良反应发现率 ,认为新药临床试验中 ,我国最低例数的规定是合理的 。

Sample size should be determined by statisti ca l estimation from efficacy analysis, but the lowest case number is necessary for safety. By calculation of the detection rate of adverse reactions, this paper s uggests that the lowest sample sizes are reasonable for Ⅱ, Ⅲ and Ⅳ stage in c linical trials in China.