新型冠状病毒肺炎疫情下肺部肿瘤临床试验面临的挑战与对策

Challenges and countermeasures of lung cancer clinical trials under epidemic of COVID-19

自2019年12月,新型冠状病毒肺炎(COVID-19)疫情席卷全球,肺癌临床试验面临诸多伦理风险与挑战。本院药物临床试验机构在质量管理体系、精准分类实施、全方位医师培养及多学科团队协作(MDT)模式及受试者筛选机制等方面形成"上海肺科模式",切实保障受试者的权益。除协助设计研究方案,临床试验组长单位亦应协助申办者讨论撰写突发情况的应急预案并将其纳入质量管理计划,以保证在临床研究中始终把保障受试者权益放在首位。

Coronavirus disease 2019(COVID-19)began to breakout throughout the world since December 2019,and the lung cancer clinical trials have faced varieties of challenges and ethical risks.The institution has formed the"Shanghai Pulmonary Hospital Mode"in terms of quality management system,precise classified implementation,comprehensive doctor training,multiple disciplinary team cooperation and subject-selecting mechanism,to effectively protect the rights and interests of subjects.In addition to assisting in the design of research plan,the clinical trial team leader unit should also assist the sponsor to discuss the preparation of emergency plans and include them in the quality management plan to ensure that the principle of protecting the rights of subjects is always the first priority in clinical research idea.