药物临床试验中的纠纷处置问题研究  

Study on Dispute Resolution in Drug Clinical Trials

作　　者：王艺霖 霍增辉[1] Wang Yilin;Huo Zenghui(Beijing University of Chinese Medicine,Beijing 102401,China)

机构地区：[1]北京中医药大学人文学院,北京102401

出　　处：《中国药事》2024年第11期1263-1268,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:通过探讨药物临床试验过程中如何在保障受试者权益的前提下,规范试验操作,减少纠纷发生,为完善我国药物临床试验法规责任制度提供建议。方法:通过对药物临床试验基本特点的分析,研究试验各主体之间的法律关系,重点分析试验纠纷中责任认定的难点及因果关系的复杂性。同时,结合中美两国药事法规和相关指南,讨论了这些关键主体可能面临的各种法规问题和责任追究方式。结果:研究发现,药物临床试验中的纠纷主要集中在知情同意的有效性、责任归属、因果关系认定及第三方鉴定的难度上。我国在药物临床试验监管上存在一些模糊之处,法规的明确性和透明度有待提高。结论:建议进一步明确关键责任主体的法规责任,并建立起互相配套、公开透明、运行规范的行业操作系统。这些措施对提升药物临床试验的规范化、保障人体试验的安全性以及促进医药行业的健康发展具有积极影响。Objective:By exploring how to regulate clinical trial operations and reduce disputes while safeguarding the rights and interests of participants,this study aims to provide recommendations for improving China's legal liability system in drug clinical trials.Methods:Through an analysis of the basic characteristics of drug clinical trials,the study examined the legal relationships between key stakeholders.It focused on the difficulties in determining liability in trial disputes and the complexity of establishing causality.Additionally,the study discussed potential regulatory issues and methods of liability attribution that these key stakeholders may face,drawing on pharmaceutical regulations and relevant guidelines from both China and the United States.Results:The research revealed that disputes in drug clinical trials are primarily concentrated around the validity of informed consent,the attribution of responsibility,the determination of causality,and the challenges associated with third-party assessments.There were certain ambiguities in China's regulation of clinical trials,and the clarity and transparency of regulations need improvement.Conclusion:It is recommended to further clarify the regulatory responsibilities of key responsible parties and establish a mutually supportive,open and transparent industry operating system with standardized operation.These measures have a positive impact on improving the standardization of drug clinical trials,ensuring the safety of human trials,and promoting the healthy development of the pharmaceutical industry.

关 键 词：药物临床试验 责任主体 法律责任 知情同意 违法处罚 

分 类 号：R95[医药卫生—药学]