非劣效设计的伦理学反思
An Ethical Reflection on Non-inferiority
王纾玥 1吴子唯 2王赵琛3
作者信息
- 1. 浙江大学医学院公共卫生学院 浙江杭州 310058;常山县疾病预防控制中心(常山县卫生监督所) 浙江衢州 324299
- 2. 浙江大学医学院公共卫生学院 浙江杭州 310058
- 3. 浙江大学医学院公共卫生学院 浙江杭州 310058;中国医学科学院北京协和医学院群医学及公共卫生学院 北京 100730
- 折叠
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.
Abstract
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.
关键词
非劣效/临床研究/临床试验/科研伦理/生命伦理Key words
non-inferiority/clinical research/clinical trials/research ethics/bioethics引用本文复制引用
出版年
2024
NETL
NSTL
万方数据