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

doi:10.19803/j.1672-8629.2021.02.01

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (2): 101-104.
DOI: 10.19803/j.1672-8629.2021.02.01

• 新型冠状病毒肺炎治疗药品安全研究专栏 • 上一篇下一篇

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

丛端端¹, 赵飞^1,△, 薛薇¹, 李可欣¹, 胡欣^2,*

¹北京医院临床试验研究中心,国家老年医学中心,中国医学科学院老年医学研究院,100730;
²北京医院药学部药物临床风险与个体化应用评价北京市重点实验室,国家老年医学中心,中国医学科学院老年医学研究院,北京 100730

收稿日期:2020-08-06 修回日期:2021-02-26 出版日期:2021-02-15 发布日期:2021-02-26
通讯作者: ^*胡欣,男,主任药师,教授·博导,临床药理、临床药学研究和医疗机构药事管理。E-mail: huxinbjyy@126.com
作者简介:丛端端,女,博士,医师,药物临床试验医学监护。^△共同第一作者。
基金资助:
国家重大新药创制科技重大专项（2017zx09101001002002）

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

CONG Duanduan¹, ZHAO Fei^1,△, XUE Wei¹, LI Kexin¹, HU Xin^2,*

¹Clinical Trial Center, Beijing Hospital; National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China;
²Department of Pharmacy, Assessment of Clinical Drugs Risk and Individual Application Key Laboratory, Beijing Hospital, National Center of Gerontology

Received:2020-08-06 Revised:2021-02-26 Online:2021-02-15 Published:2021-02-26

摘要/Abstract

摘要： 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。

关键词: 临床试验, 新型冠状病毒肺炎, 药物临床试验质量管理规范

Abstract: 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.

Key words: clinical trials, coronavirus disease 2019, good clinical practice

中图分类号:

R954.2

丛端端, 赵飞, 薛薇, 李可欣, 胡欣. 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[J]. 中国药物警戒, 2021, 18(2): 101-104.

CONG Duanduan, ZHAO Fei, XUE Wei, LI Kexin, HU Xin. Clinical Research of COVID-19 Based on Good Clinical Practices for Clinical Trials of Drugs[J]. Chinese Journal of Pharmacovigilance, 2021, 18(2): 101-104.

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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

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