医药导报2026,Vol.45Issue(6):1051-1057,7.DOI:10.3870/j.issn.1004-0781.2026.06.016
国内外药物临床试验补偿与赔偿制度比较及启示
Comparison and Implications of Compensation and Indemnification Systems in Drug Clinical Trials Between China and Foreign Countries
徐伟珍 1李飞燕 1张璐1
作者信息
- 1. 浙江省肿瘤医院,中国科学院杭州医学研究所临床研究部,杭州 310022
- 折叠
摘要
Abstract
By comparing the interpretations,laws,regulations,and systems of participant's compensation and indemni-fication in drug clinical trials across regions such as the EU,the United States,Asia,and Australia.This study analyzes the scope of application,responsible entities,criteria formulation,payment methods and dispute resolution mechanisms for compensation and indemnification.By comparing the strengths and limitations of these practices' system,we aim to provide empirical evidence and theoretical support for optimizing China's compensation and indemnification regime and strengthening the protection of partici-pants' rights and interests.关键词
药物临床试验/补偿/赔偿/试验参与者权益保护Key words
Drug clinical trials/Compensation/Indemnification/Protection of trial participants' rights and interests分类
医药卫生引用本文复制引用
徐伟珍,李飞燕,张璐..国内外药物临床试验补偿与赔偿制度比较及启示[J].医药导报,2026,45(6):1051-1057,7.