药物临床试验纠纷相关问题研究

Research on Related Issues of Drug Clinical Trial Disputes

药物临床试验是指以人体(患者或健康受试者)为对象的试验,意在发现或证实某种试验药物的临床医学、药理学以及其他药效学作用、不良反应,或者试验药物的吸收、分布、代谢和排泄,以确定药物的疗效与安全性的系统性试验。药物临床试验是新药研发上市的必经程序,是推动医学发展进步的重要路径。随着我国医药研究和医药产业的快速发展,药物临床试验的数量持续快速增加,由此引发的纠纷数量也在逐渐增多,纠纷处置实践中也出现一些难题。本研究在梳理和探讨药物临床试验的基本特点、须遵循的基本伦理原则、知情同意书的法律定位以及药物临床试验纠纷处置实践中存在问题的基础上,给出健全药物临床试验保险相关规制、探索建立专门的鉴定机构及专家队伍等完善药物临床试验纠纷处置的意见建议,以期为药物临床试验相关纠纷的处理提供理论参考。

Drug clinical trials refer to systematic test or research conducted on human subjects(patients or healthy volunteers)with the intention of discovering or confirming the clinical,pharmacology and other pharmacodynamics effects,adverse effects,or the absorption,distribution,metabolism,and excretion of experimental drug,to determine its efficacy and safety of drug.Drug clinical trial is not only an essential process for the development and launching of new drugs,but also the basis for the advancement of medicine.However,with the rapid development of the pharmaceutical industry and the fast growth of clinical trials,the number of disputes related to clinical trials is also rising,and there are some difficulties in the practice of dispute handling.This study systematically analyzed the fundamental characteristics of drug clinical trials,the basic ethical principles to be followed,the legal position of informed consent forms,and the problems existing in the practice of resolving drug clinical trial disputes.Based on that,the study provided suggestions on improving the regulations of insurance related to clinical trials,and proposed to establish specialized appraisal institutions and expert teams to handle disputes related to clinical trials,so as to provide theoretical reference for the handling of related disputes.