模拟验证等效性检验中β的单、双侧取值

The Determination of β in Bioequivalence Test by Monte Carlo Simulation

目的研究临床试验中等效性检验的样本量的计算问题。方法在概括总结影响等效性检验的样本量与检验效能的几个主要因素(α、β、θ、Δ、σ)的基础上,重点介绍了等效性检验中α与β的确定与含义,并指出了文献中所存在的分歧;然后利用计算机抽样模拟的方法,依据不同设计类型、不同参数取值下计算的样本量,模拟估算所对应的检验效能。结果模拟验证了β应该取单侧还是双侧并给出了较为合理的解释。结论在等效性检验的样本量估算中,当θ为0时,β取双侧;当θ不等于0时,β取单侧。

Objective To study the sample size calculation of bioequivalence test in clinical trial. Methods Summarized the factors which affected power and sample size in traditional and equivalence test such as α、β、θ ,△and δ, and introduced the meaning of α and βin detail, what＇ s more, we pointed out the divergence in literatures about this topic. Then the Monte Carlo simulations were used to estimate power in a given sample size calculated by traditional formulation with different designs, different θ and CV. Results we confirmed whether β should be one - sided or two - sided in equivalence test and gave the rational explanation. Conclusion β should be two - sided when θ is zero in calculation of sample size of bioequivahnee test, otherwise, β is one - sided.