新药临床非劣性及等效性试验中的例数估计和等效标准

Sample size estimation and equivalence margin in noninferiority and equivalence trials

根据新药临床研究的要求和特点 ,提出临床非劣性及等效性试验例数估计的简算法和查表法 ,并探讨确定等效标准 (δ)的几种方法 ,可供例数估算时参考。

Based on the character and requirement of new drug clinical trials,a simple algorithm for sample size estimation and some methods for determination of equivalence margin (δ) in noninferiority and equivalence clinical trials were provided in this paper.