新型冠状病毒肺炎疫情下拓展性临床试验的伦理审查挑战

The Challenge of Review of Extended Clinical Trials in the Context of an Epidemic of COVID-19

迄今尚无新型冠状病毒肺炎的特效药物,危重患者有参加拓展性临床试验(也称同情用药)的迫切需求。拓展性临床试验是临床试验的一种形式,其使用的临床试验用药物的安全性和有效性仍需验证。因此,申请程序、伦理审查、知情同意等都是保护拓展性临床试验受试者权益的重要举措。中国虽有拓展性临床试验的原则性法规,但尚未出台配套的详细规定。借鉴美国拓展性临床试验的成熟经验,结合中国国情,应完善法规,明确分类、申请人、申请程序和各方责任以保障受试者权益,并鼓励企业开展拓展性临床试验,以加快在中国落地,惠及更多患者。伦理委员会要重点审查研究方案、风险受益比、知情同意、是否收费、跟踪审查、各方责任等,确保受试者权益,助推中国拓展性临床试验的规范化建设。

So far,there is no specific drug for 2019 coronavirus disease,and critical patients have an urgent need to participate in extended clinical trials(also known as compassionate medication).Extended clinical trial is a form of clinical trial,the safety and effectiveness of the drugs used in clinical trial still need to be verified.Therefore,application procedure,ethical review and informed consent are all important measures to protect the rights and interests of the subjects in the extended clinical trial.Although China has the principles and regulations for the extended clinical trials,it has not yet issued the supporting detailed regulations.Referring to the mature experience of the US extended clinical trials and combining with China’s national conditions,we should improve laws and regulations,clarify the classification,applicant,application procedures and responsibilities of all parties to protect the rights and interests of the subjects,and encourage enterprises to carry out extended clinical trials,so as to accelerate the landing in China and benefit more patients.The ethics committee should focus on the review of research program,the risk-benefit ratio,informed consent,whether to charge,follow-up review,and responsibilities of all parties,so as to ensure the rights and interests of the subjects and promote the standardized construction of extended clinical trials in China.