基于药物临床试验质量管理规范对新型冠状病毒肺炎相关临床研究的思考和建议

Clinical Research of COVID-19 Based on Good Clinical Practices for Clinical Trials of Drugs

目的针对现有新型冠状病毒肺炎(coronavirus disease 2019,COVID-19)相关临床试验中出现的若干问题展开思考和讨论,为后续试验的开展及监管实施提供参考。方法结合2020版《药物临床试验质量管理规范》,通过文献研究等方法对现有COVID-19相关临床试验进行研究。结果快速增长的COVID-19相关临床试验,在推动疫苗和药物研发进程,加深学界对于新型冠状病毒致病机理,疾病特征的认识的同时,也暴露出设计缺陷,研究资源浪费,监管困难等诸多问题。结论国家药品监督管理部门与卫生健康委员会应结合各国经验,凝聚专家意见,进一步优化资源分配,通过推动高质量、高效率的临床试验,培养专业性的临床试验人才队伍,促进和健全国家公共卫生应急管理体系。

Objective To review several issues arising from the current clinical trials of coronavirus disease 2019(COVID-19)so as to promote subsequent trials and regulation.Methods In line with the new version of Good Clinical Practices for Clinical Trials of Drugs(2020 edition),the on-going COVID-19-related clinical trials were studied through an exhaustive literature search.Results The surge of COVID-19 related clinical trials had advanced our understanding of the characteristics and pathogenic mechanisms of SARS-CoV-2,and promoted the development of vaccines and drugs.However,many problems also arose,such as design flaws,waste of research resources,and regulatory difficulties.Conclusion The National Medical Products Administration(NMPA)and the National Health Commission(NHC)should draw on the experience of our own and other countries,solicit expert opinions and continue to optimize resource allocation.By promoting high-quality and high-efficiency clinical trials and nurturing professional clinical researchers,the national public health emergency management system will be improved substantially.