非劣效抗肿瘤药物临床试验样本量的估算  

Estimation of sample size for non-inferiority anti-tumor drugs clinical trails

作　　者：张雷[1] ZHANG Lei(Peking University Cancer Hospital,Medical Ethics Committee,Beijing 100142,China)

机构地区：[1]北京大学肿瘤医院医学伦理委员会,北京100142

出　　处：《中国研究型医院》2023年第2期11-15,共5页Chinese Research Hospitals

摘　　要：非劣效抗肿瘤药物临床试验在新药的开发和临床推广应用中具有重要作用,其样本量的估算是临床试验的关键环节。本研究中,结合相关文献,按不同的分析和评价指标(计量指标、计数指标、生存分析),结合实例探讨需要考虑的效应量和统计特征,以及样本量的估算过程。非劣效抗肿瘤药物临床试验样本量的估算,首先要明确非劣效界值,然后根据临床试验涉及的不同分析和评价指标确定相应的效应量,选择相匹配的统计特征,才能准确估算样本量。临床试验中,足够的样本量是提高试验科学性和研究结果准确性的重要条件之一。Clinical trials of non-inferiority anti-tumor drugs play an important role in the development and clinical promotion of new drugs.Sample size estimation is a key aspect of these trials.This study combines relevant literature and discusses the effect size and statistical characteristics that need to be considered,as well as the process of sample size estimation based on different analysis and evaluation indicators(metric indicators,count indicators,survival analysis)through examples.To estimate the sample size of non-inferiority anti-tumor drug clinical trials,it is necessary to first clarify the non-inferiority margin.Then,determine the corresponding effect size according to the different analysis and evaluation indicators involved in clinical trials,and choose matching statistical characteristics to accurately estimate the sample size.A sufficient sample size is essential to improve the scientific nature of the trials and the accuracy of the research results.

关 键 词：临床试验 药物筛选试验 抗肿瘤 样本大小 非劣效 计算 

分 类 号：R95[医药卫生—药学]