中国医学伦理学2026，Vol.39Issue(6)：754-761,8.DOI:10.12026/j.issn.1001-8565.2026.06.08
非劣效性设计临床试验的伦理审查要点
Key points of ethical review for non-inferiority clinical trials
高峰平 1张卫中2
作者信息
- 1. 杭州市五云山医院/杭州市健康促进研究院检验科,浙江 杭州 310008
- 2. 杭州市五云山医院/杭州市健康促进研究院伦理委员会,浙江 杭州 310008
- 折叠
摘要
Abstract
The iteration speed of drug innovation and novel therapeutic methods has fallen far short of expectations.Scientists have gradually shifted their focus to drugs or treatments that exhibit efficacy comparable to standard therapies but with fewer side effects,greater convenience,or lower costs.The application scenarios of non-inferiority trials(NITs)are gradually increasing.Among these,the rationality of the potential benefits in secondary indicators served as a prerequisite for implementing NITs.Ethics committees should conduct a thorough review of major parameters such as thresholds,positive controls,and sample size,make an overall judgment on trial quality,fully interpret the statistical analysis of study results and non-inferiority conclusions,and rigorously review informed consent forms.Only in this way can the smooth conduct of clinical trials be ensured,enabling more drugs and treatments with clinical benefits to enter clinical practice,advancing the development of medical research,and ultimately safeguarding the rights and interests,along with the safety of research participants.关键词
非劣效性设计/临床试验/伦理审查Key words
non-inferiority trials/clinical trial/ethical review分类
医药卫生引用本文复制引用
高峰平,张卫中..非劣效性设计临床试验的伦理审查要点[J].中国医学伦理学,2026,39(6):754-761,8.
