Attaching importance to the design process to improve the quality of clinical trials in China_Chinese Journal of Evidence-Based Medicine

Authors：

ZHAO Chen ¹ , LAM Waiching ¹ , TIAN Ran ¹ , YANG Zhen ¹ , LYU Aiping ¹ ,  SHANG Hongcai ² ,  BIAN Zhaoxiang ¹

1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, 999077, P.R.China;
2. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;

Corresponding author：

SHANG Hongcai, Email: shanghongcai@foxmail.com; BIAN Zhaoxiang, Email: bianzxiang@gmail.com

Keywords：

Clinical trial design; Clinical trial quality; Clinical problems; Clinical trial methodology; Control design

DOI：

10.7507/1672-2531.201801064

Video：

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Evidence produced by clinical trial is the main basis for health care decision-making at all levels. In recent years, some problems been revealed in the national data audit of new drug clinical trials have sounded the alarm for the quality of clinical research in China. In addition to strengthening the implementation of clinical trial process management and supervision, we call attention to the coherence and consistency of trial design and implementation, including the promotion of clinical trial design in the agenda of improving the quality of the trials and putting forward reasonable suggestions. We hope that our work could make research ideas clear from the source of a clinical trial, with a view to avoid violating protocol behavior and provide standardized recommendations for improving the quality of clinical trials in China.

Citation： ZHAO Chen, LAM Waiching, TIAN Ran, YANG Zhen, LYU Aiping, SHANG Hongcai, BIAN Zhaoxiang. Attaching importance to the design process to improve the quality of clinical trials in China. Chinese Journal of Evidence-Based Medicine, 2018, 18(7): 645-647. doi: 10.7507/1672-2531.201801064 Copy

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9.	张宏伟, 刘建平. 临床试验中的结局指标及效应测量. 中医杂志, 2007, 48(8): 696-698.
10.	胡晶, 刘卫红, 张会娜, 等. " 病证结合”多主要终点评价法在中医药临床研究中的应用. 世界中医药, 2017, 12(6): 1214-1217.
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12.	王云飞, 阮新民, 吴焕林, 等. 大型双盲临床试验中药安慰剂制备方法及效果评价研究. 中药新药与临床药理, 2011, 22(3): 255-258.
13.	唐旭东, 卞立群, 高蕊, 等. 中药临床试验安慰剂制作探讨. 中国中西医结合杂志, 2009, 29(7): 656-658.
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1. Zhao L, Chen J, Li Y, et al. The long-term effect of acupuncture for migraine prophylaxis: a randomized clinical trial. JAMA Intern Med, 2017, 177(4): 508-515.
2. Liu Z, Liu Y, Xu H, et al. Effect of electro acupuncture on urinary leakage among women with stress urinary incontinence: a randomized clinical trial. JAMA, 2017, 317(24): 2493-2501.
3. 国家食品药品监督管理总局. 关于开展药物临床试验数据自查核查工作的公告(2015年第117号). Available at: http://www.sda.gov.cn/WS01/CL0050/124800.html.
4. 国务院办公厅. 国务院办公厅关于开展仿制药质量和疗效一致性评价的意见(国办发〔2016〕8号). Available at: http://www.gov.cn/zhengce/content/2016-03/05/content_5049364.html.
5. 国家食品药品监督管理总局. 关于药物临床试验数据核查有关问题处理意见的公告(2017年第63号). Available at: http://www.sda.gov.cn/WS01/CL1278/172936.html.
6. 国家食品药品监督管理总局. 关于发布普通口服固体制剂参比制剂选择和确定等3个技术指导原则的通告(2016年第61号). Available at: http://www.sda.gov.cn/WS01/CL1751/147583.html.
7. Alain S. Methodology of clinical drug trials. Basel: Karger, 1985.
8. Li V, Carter SM, Rychetnik L. Evidence valued and used by health promotion practitioners. Health Educ Res, 2015, 30(2): 193-205.
9. 张宏伟, 刘建平. 临床试验中的结局指标及效应测量. 中医杂志, 2007, 48(8): 696-698.
10. 胡晶, 刘卫红, 张会娜, 等. " 病证结合”多主要终点评价法在中医药临床研究中的应用. 世界中医药, 2017, 12(6): 1214-1217.
11. Kirkham JJ, Gorst S, Altman DG, et al. Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. PLoS Med, 2016, 13(10): e1002148.
12. 王云飞, 阮新民, 吴焕林, 等. 大型双盲临床试验中药安慰剂制备方法及效果评价研究. 中药新药与临床药理, 2011, 22(3): 255-258.
13. 唐旭东, 卞立群, 高蕊, 等. 中药临床试验安慰剂制作探讨. 中国中西医结合杂志, 2009, 29(7): 656-658.
14. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med, 2013, 158(3): 200-207.

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