中国医学伦理学2026，Vol.39Issue(1)：58-63,6.DOI:10.12026/j.issn.1001-8565.2026.01.08
药物临床试验"修正案"伦理审查的管理与实践
Management and practice of ethical review for"amendment"in drug clinical trials
摘要
Abstract
Driven by the growing practical need to accelerate drug development and the continuous innovation of trial design in recent years,the number of protocol amendments during clinical trials have gradually increased,and the changed contents have become more flexible and complex,which significantly heightens the difficulty of ethical review on amendments.Against this backdrop,it is of great importance to fully leverage the role and responsibilities of ethics committees,effectively control clinical trial risks,and ensure subject safety.This paper analyzed development trends of protocol amendments in recent years,sorted out requirements for protocol amendments in Chinese regulations and guiding principles,and examined difficulties of amendment ethical review in practical work.Based on these,targeted strategies and recommendations were proposed,namely,strengthening the integration with scientific review,enhancing the formal review,adjusting the scope of review according to approval notifications,and adopting appropriate review methods,with a view to providing insights and references for the management of the amendment ethical review in drug clinical trials.关键词
药物临床试验/伦理审查/修正案Key words
drug clinical trial/ethical review/amendment分类
医药卫生引用本文复制引用
李星颐,陈仲林,瞿幸池,冯钰,韩慧慧..药物临床试验"修正案"伦理审查的管理与实践[J].中国医学伦理学,2026,39(1):58-63,6.基金项目
上海申康医院发展中心第二轮《促进市级医院临床技能与临床创新三年行动计划》研究型医师创新转化能力培训项目"生物医药创新背景下医院临床研究的伦理审查体系建设"(SHDC2023CRS046) （SHDC2023CRS046）
