Case analysis and management of research-related injury compensation of drug clinical trials

VernacularTitle:药物临床试验损害赔偿案例分析及管理思考
Author: Pinrong CAO ¹ ; Xin ZHOU
Author Information

1. 中国人民解放军联勤保障部队第九〇〇医院药剂科，福州　350000
Keywords: Drug clinical trial research-related injury; Human subject rights protection; Damage prevention; Damage treatment
From: Chinese Journal of Medical Science Research Management 2022;35(1):12-15
CountryChina
Language:Chinese
Abstract: Objective:To propose suggestions on the prevention and treatment measures of drug clinical trial research-related injury from the research center perspective, and improve the protection of the rights of human subjects.Methods:Analyze three representative cases of drug clinical trial research-related injury compensation in a hospital, and put forward suggestions for the project management of the research center.Results:By reviewing informed consent forms and clinical trial liability insurance, actively participating in research-related injury treatment and implementation supervision, paying attention to safety information and risk monitoring, ethics committees, clinical trial institutions and investigators can play more proactive roles in protecting the rights and interests of human subjects.Conclusions:The research center could better control the risks of clinical trials and improve the protection of human subjects by strengthening the prevention and treatment measures for clinical trial research-related injury.