The study of the quality control of clinical research related to the prevention and treatment by traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

ZHU Ping ¹ , LI Jiaqi ² ,  DENG Hongyong ¹

1. Shanghai University of Traditional Chinese Medicine, Shanghai 201203, P. R. China;
2. Department of Oncology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 2000437, P. R. China;

Corresponding author：

DENG Hongyong, Email: denghy@shutcm.edu.cn

Keywords：

Corona virus disease 2019; Clinical research; Quality control; Evidence-based medicine

DOI：

10.7507/1672-2531.202206108

Video：

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The scientific research on prevention and control of coronavirus disease 2019 (COVID-19) has been a major and urgent task, of which clinical trials occupy a pivotal position in the entire prevention and control system. 204 relative clinical trials of traditional Chinese medicine (TCM) have been registered on Chinese Clinical Trial Registry. Through the analysis of all online public protocols of registered trials, it is found that the clinical studies of TCM in China showed lack of research foundation, tight time and heavy tasks, difficult clinical implementation, and disturbance by changes of the epidemic status. Based on these characteristics, this paper put forward several thoughts and suggestions on the quality management and design improvement for clinical trials of TCM preventing and treating COVID-19, in order to improve the quality of clinical trials in China, provide effective supports for the public health decision-making on the epidemic, and also give a reference for the prevention and control of epidemics in the future.

Citation： ZHU Ping, LI Jiaqi, DENG Hongyong. The study of the quality control of clinical research related to the prevention and treatment by traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2023, 23(1): 94-98. doi: 10.7507/1672-2531.202206108 Copy

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1. Rajpal VR, Sharma S, Kumar A, et al. "Is Omicron mild". Testing this narrative with the mutational landscape of its three lineages and response to existing vaccines and therapeutic antibodies. J Med Virol, 2022, 94(8): 3521-3539.
2. Delorey TM, Ziegler CGK, Heimberg G, et al. COVID-19 tissue atlases reveal SARS-CoV-2 pathology and cellular targets. Nature, 2021, 595(7865): 107-113.
3. Xu P, Xing X, Yu K, et al. Profiles of COVID-19 clinical trials in the Chinese clinical trial registry. Emerg Microbes Infect, 2020, 9(1): 1695-1701.
4. 中国临床试验注册中心. 新型冠状病毒肺炎临床研究索引, 2020-09-19. Available at: http://www.chictr.org.cn/index.aspx.
5. Cohen J. Chinese researchers reveal draft genome of virus implicated in Wuhan pneumonia outbreak. Science, 2020. DOI: 10.1126/science.aba8829.
6. 耿希, 顾翠峰, 周文超, 等. 新型冠状病毒肺炎疫情下临床研究伦理审查工作的实践与思考. 上海中医药杂志, 2020, 54(7): 10-12.
7. 曾宪涛, 朱风雷, 任学群, 等. 基于临床科研一体化技术的临床研究. 中国循证心血管医学杂志, 2017, 9(10): 1156-1161.
8. 杜斌, 邱海波, 詹曦, 等. 新型冠状病毒肺炎药物治疗的思考. 中华结核和呼吸杂志, 2020, 43(3): 173-176.
9. 尚伟锋, 李维, 周登峰, 等. 新型冠状病毒肺炎临床特征的Meta分析. 临床荟萃, 2020, 35(4): 293-296.
10. 李大灿, 黄敏, 赵彩莲, 等. 新冠肺炎疫情防控中5G智慧医疗服务体系的构建. 中华急诊医学杂志, 2020, (4): 503-508.
11. 弓孟春, 刘莉, 吴琛, 等. 传染病爆发流行期间的临床研究方法与卫生经济学考量. 南方医科大学学报, 2020, 40(3): 353-357.
12. 国家卫生健康委办公厅. 关于加强信息化支撑新型冠状病毒感染的肺炎疫情防控工作的通知. 中国护理管理, 2020, 20(2): 163.
13. 张雪艳. 传染病护理中的常见伦理冲突与控制对策研究. 中国社区医师, 2018, 34(18): 154-155.
14. 丁蕾, 蔡伟, 丁健青, 等. 新型冠状病毒感染疫情下的思考. 中国科学: 生命科学, 2020, 50(3): 247-257.
15. WHO. 传染病暴发伦理问题管理指南. 熊宁宁, 译. 北京: 中国中医药出版社, 2020: 4-27.
16. 曾繁典. 新型冠状病毒肺炎疫情下相关临床试验的伦理考量. 医药导报, 2020, 39(3): 313-314.
17. 元唯安, 胡义扬, 唐健元, 等. 当下新型冠状病毒肺炎中药临床研究的若干思考. 上海中医药杂志, 2020, 54(4): 1-5.
18. 国家卫生健康委员会. 新型冠状病毒肺炎诊疗方案(试行第九版). 传染病信息, 2022, 35(2): 97-106.
19. Pak K, Jacobus S, Uno H. Decision on performing interim analysis for comparative clinical trials. Contemp Clin Trials Commun, 2017, 7: 224-230.
20. 张湘敏, 吕梁, 陈建福, 等. COVID-19临床诊疗及防控进展. 重庆医科大学学报, 2020, 45(7): 849-852.

Chinese Journal of Evidence-Based Medicine

The study of the quality control of clinical research related to the prevention and treatment by traditional Chinese medicine

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