摘要
非劣效设计作为一类重要的试验类型,在国内外临床科研中愈发普遍。相较于更多对其科学性的关注,科研伦理、研究参与者权益保护的讨论较为不足。结合国内外文献、指导原则与实践案例,重点分析非劣效设计的合理性基础;剖析了各类次要指标、尤其是定价将更便宜所引发的概念问题与伦理张力。建议研究者、审查机构与监管部门明晰非劣效设计的适用情形,在确保研究参与者合理权益的前提下,以追求至善的伦理关怀促进临床研究高质量发展。
Non-inferiority,as a crucial experimental approach,has gained popularity in domestic and overseas clinical research.However,discussions on research ethics and safeguarding participants'rights and interests are relatively inadequate compared to the emphasis placed on its scientific validity.This paper examines the rationality of non-inferiority by analyzing domestic and foreign literature,guiding principles,and practical cases.It explores conceptual challenges and ethical tensions related to secondary advantageous outcomes,particularly those involving cost-effectiveness considerations.It is imperative for researchers,institutional review boards,and regulatory authorities to clearly define appropriate guidelines for non-inferiority on the premise of ensuring the legitimate rights and interests of research participants.Promoting the high-quality development of clinical research needs ethical guidance in the light of pursuing the supreme good.
作者
王纾玥
吴子唯
王赵琛
WANG Shuyue;WU Ziwei;WANG Zhaochen(School of Public Health,School of Medicine,Zhejiang University,Hangzhou 310058,China;Changshan County Center for Disease Control and Prevention(Changshan Institute of Public Health Supervision),Quzhou 324299,China;School of Population Medicine and Public Health,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China)
出处
《医学与哲学》
北大核心
2024年第6期23-26,共4页
Medicine and Philosophy
关键词
非劣效
临床研究
临床试验
科研伦理
生命伦理
non-inferiority
clinical research
clinical trials
research ethics
bioethics
