药物临床试验合作中的法律风险识别与防控

Legal risk identification and prevention in drug clinical trial cooperation

目的:为申办方和研究机构在药物临床试验合作中的合规化管理提供参考。方法:以中国裁判文书网上关于药物临床试验的典型案例为依据,结合文献研究方法,从宏观和微观角度研究药物临床试验合作过程中的法律风险、成因、对策。结果:总体来看,药物临床试验合作中的违规行为可能遭受到民事责任、行政处罚、刑事制裁。从微观来看,申办方和研究机构普遍存在怠于审查临床试验合同、不当管理临床试验质量和忽视受试者保护的情况。从宏观来看,药物临床试验的法律政策呈现非体系化,药物临床试验的监管呈现趋严化。结论:申办者和研究机构应适应新政策下的新要求,提高主体责任,追求更高标准的合规要求,以期在保障临床试验中受试者安全的同时,最大化地维护自身合法权益,防范法律风险。

Objective:To provide reference for the compliance management of sponsors and research institutions in drug clinical trial cooperation.Methods:Based on the typical cases of drug clinical trials in Chinese Judgment Documents Online,this paper studies the legal risks,causes and countermeasures in the process of drug clinical trial cooperation from both macro and micro perspectives.Results:Overall,violations of drug clinical trial cooperation are probably subject to civil liability,administrative penalties,and criminal sanctions.At the micro level,both sponsors and research institutions generally neglect to review the clinical trial contracts,improperly manage clinical trial quality,and neglect subject protection.At the macro level,the legal policies of drug clinical trials are non⁃systematic,and the supervision of drug clinical trials is becoming stricter.Conclusion:The sponsors and research institutions should adapt to the new requirements under the new policy,improve the main responsibility,and pursue higher standards of compliance requirements,in order to ensure the safety of subjects in clinical trials,while maximizing their legitimate rights and interests,thus preventing legal risks.