AIM: To develop a method to calculate sample siz e for related rate non-inferior trial.METHODS: Design SAS Macr ore to calculate sample size for related rate in non-inferior trial by sim ulation.

• 目的:当评价指标为定性指标时,利用相对率作为标准判断非劣效性是一种方便易行的方法,本文目的在于解决这一背景下的样本量计算问题。