新型冠状病毒肺炎疫情下药物临床研究的伦理思考

Ethical Considerations on Drug Clinical Trial in the Outbreak of Novel Coronavirus-infected Pneumonia

通过对新型冠状病毒肺炎疫情下国内相关药物临床研究的现状进行分析和梳理,发现其伦理考量的特殊性在于疾病爆发时期的同情治疗与临床研究的关系、风险与受益评估的特殊考虑、利益回避和伦理监督管理等方面。在伦理审查机制体制上,国家层面应该建立统一的、针对突发公共卫生事件中的临床试验的伦理审查工作制度,将紧急情况下开展的临床试验由各级医疗机构管理上升为国家层面的审批制,从而才能从源头上保障突发公共卫生事件下的临床研究项目规范有序开展,不会因重大疫情下患者和社会的迫切需求而降低研究质量,浪费临床资源和社会资源。

This paper analyzes the current status of domestic drug clinical trails in the outbreak of novel coronavirus-infected pneumonia.It claims that the specific ethical considerations lie in the relation between compassionate use and clinical trial,special considerations on risk-benefit assessment,the management of conflict of interests,and the ethical oversight.From the perspective of ethical review mechanism,in the national level it needs to establish an ethical review system for clinical trials in public health emergencies,and upgrade clinical trials in emergency from institutional oversight to national approval.In this way,it will ensure the standardized and orderly development of clinical research in public health emergencies from the root,in terms of avoiding reducing the quality of research and wasting clinical and social resources due to the urgent needs of patients and society during the disease outbreak.