Analysis of civil liability and risk response to adverse event disputes in drug clinical trials
ZHAO Tian-jiao
DENG Yong
Abstract：In recent years,China's new drug R&D and drug clinical trials have developed rapidly.The clinical trials of the drugs have received increasing public attention and further promotion and development.At the same time,civil legal disputes arising from adverse events in drug clinical trials are also frequently met.Therefore,it is of practical significance to analyze the civil legal liability of the sponsor and the research institution in such disputes,to identify and prevent the litigation risks,and to explore the resolution path of the civil disputes that have occurred.Through the analysis of the legal relationship between the main subjects in the drug clinical trial disputes,combining relevant judicial cases,the situation and risk of the sponsor and the research institution bearing civil liability are discussed in this article.From the aspects of establishing a risk management and control mechanism,strengthening the protection of subjects'right to informed consent,attaching importance to the qualification review and professional quality of the research team,and giving full play to the role of judicial advice of the court and the supervision of the procuratorate,the legal liability risk in drug clinical trials should be avoided.The measures should be taken to deal with the disputes that have occurred,such as self-review and improvement of the compensation,compensation mechanism of subjects,and strengthening supervision and inspection.
Keywords：drug clinical trialadverse event civil disputecivil liabilityrisk avoidance and response
Publication Date：2025-03-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 498-504 )