Comparison of drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, and completion_Chinese Journal of Evidence-Based Medicine

Authors：

LI Jiayu ^1,2 , LI Huijuan ² , LI Chenglong ¹ , CHEN Xiayan ² , ZHANG Xiaofang ^1,2 ,  WU Yangfeng ²

1. Peking University First Hospital, Beijing 100191, P.R.China;
2. Institute for Clinical Research, Peking University, Beijing 100191, P.R.China;

Corresponding author：

WU Yangfeng, Email: wuyf@bjmu.edu.cn

Keywords：

Drug; Clinical trial; Trial design; Completion; Results disclosure

DOI：

10.7507/1672-2531.202102031

Video：

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Objective To compare drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, completion and results publication.Methods We randomly selected 190 clinical trials that were registered in ClinicalTrials.gov from 2009 to 2014, and followed up to December 31^st, 2019. Comparisons were made for the type of sponsor, phase, design, and completion status by the sponsor’s country.Results Among all included clinical trials, trials from the United States, Europe, Japan and China accounted for 50.5%, 34.2%, 9.0% and 6.3%, respectively. Among these trials, 71.1% had been completed and 69.5% disclosed results had been published publicly prior to the end of follow-up, and differences between countries were statistically significant (P<0.05). Two-thirds of the trials in China were phase Ⅲ/Ⅳ trials; in contrast, most of the clinical trials in the United States and Europe were phase Ⅰ/Ⅱ trials. The proportion of using double-blind, randomized controlled trial design was the highest in the United States (46.9%) and the lowest in China (8.3%). Chinese sponsors were mostly hospitals/universities (58.3%), while in other countries drug trials were mostly sponsored by the industry and in Japan the proportion was as high as 94.0%.Conclusions The number of drug trials registered in ClinicalTrials.gov from China is small and these trials are less likely to be completed and have results published/disclosed. Pharmaceutical companies in China should pay more attention to the public registration of their clinical trials, particularly those in early phases, and improve trial design and management.

Citation： LI Jiayu, LI Huijuan, LI Chenglong, CHEN Xiayan, ZHANG Xiaofang, WU Yangfeng. Comparison of drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, and completion. Chinese Journal of Evidence-Based Medicine, 2021, 21(7): 845-850. doi: 10.7507/1672-2531.202102031 Copy

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8.	ICH. China Food and Drug Administration joins ICH. Available at: https://www.ich.org/pressrelease/ich-assembly-montreal-canada-mayjune-2017.
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13.	Shiokawa T. Background, introduction and activity of the Japan primary registries network. J Evid Based Med, 2009, 2(1): 41-43.
14.	Watson R. European Medicines Agency changes policy on clinical trial data publication. BMJ, 2014, 348: g4073.
15.	World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 2013, 310(20): 2191-2194.
16.	陈君超. 从试验注册到结果公开进一步提高临床试验的透明化. 中国新药杂志, 2018, 27(20): 2357-2360.
17.	Tumber MB, Dickersin K. Publication of clinical trials: accountability and accessibility. J Intern Med, 2004, 256(4): 271-283.
18.	De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Lancet, 2004, 364(9438): 911-912.
19.	邬兰, 田国祥, 王行环, 等. 临床试验的注册及注册平台比较分析. 中国循证心血管医学杂志, 2017, 9(2): 129-134.
20.	Hasselblatt H, Dreier G, Antes G, et al. The German clinical trials register: challenges and chances of implementing a bilingual registry. J Evid Based Med, 2009, 2(1): 36-40.
21.	Jiménez G, Pascual MA, Fors M, et al. The Cuban public registry of clinical trials: primary registry of World Health Organization. J Evid Based Med, 2011, 4(3): 161-164.
22.	Wu T, Li Y, Liu G, et al. Chinese clinical trial registry: mission, responsibility and operation. J Evid Based Med, 2011, 4(3): 165-167.
23.	Askie LM. Australian New Zealand clinical trials registry: history and growth. J Evid Based Med, 2011, 4(3): 185-187.
24.	李昕雪, 韩梅, 王禹毅, 等. 临床试验的国际注册及在美国临床试验注册平台注册的意义与方法. 中医杂志, 2013, 54(19): 1640-1643.
25.	梁晨. 对转型时期我国药品监管体制的宏观思考. 中国卫生政策研究, 2015, 8(4): 18-23.

1. 武阳丰, 方伟岗. 论我国医科院校如何发展高水平临床研究. 北京大学学报(医学版), 2019, 51(3): 384-389.
2. Johnson J, Vishal Gupta N. Recent advances in quality management of clinical trials. J Pharm Pharm Sci, 2013, 5(3): 34-38.
3. Gordon BG, Kessinger A, Mann SL, et al. The impact of escalating regulatory requirements on the conduct of clinical research. Cytotherapy, 2003, 5(4): 309-313.
4. Camilleri M, Tremaine WJ. Governance of clinical research. Am J Gastroenterol, 2012, 107(3): 336-338.
5. Zarin DA, Tse T, Menikoff J. Federal human research oversight of clinical trials in the United States. JAMA, 2014, 311(9): 960-961.
6. National Institutes of Health, Department of Health and Human Services. Clinical trials registration and results information submission. Final rule. Fed Regist, 2016, 81(183): 64981-5157.
7. 周江华, 董碧蓉. 通过推进注册提升临床试验研究质量. 现代临床医学, 2016, 42(6): 469-470.
8. ICH. China Food and Drug Administration joins ICH. Available at: https://www.ich.org/pressrelease/ich-assembly-montreal-canada-mayjune-2017.
9. Wolfenden L, Ziersch A, Robinson P, et al. Reducing research waste and improving research impact. Aust N Z J Public Health, 2015, 39(4): 303-304.
10. Zarin DA, Keselman A. Registering a clinical trial in ClinicalTrials. gov. Chest, 2007, 131(3): 909-912.
11. Zarin DA, Tse T. Moving toward transparency of clinical trials. Science, 2008, 319(5868): 1340-1342.
12. 吴泰相, 李幼平, 刘关键, 等. 中国临床试验注册中心及中国循证医学中心提高我国临床试验质量的策略和措施. 中国循证医学杂志, 2010, 10(11): 1243-1248.
13. Shiokawa T. Background, introduction and activity of the Japan primary registries network. J Evid Based Med, 2009, 2(1): 41-43.
14. Watson R. European Medicines Agency changes policy on clinical trial data publication. BMJ, 2014, 348: g4073.
15. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 2013, 310(20): 2191-2194.
16. 陈君超. 从试验注册到结果公开进一步提高临床试验的透明化. 中国新药杂志, 2018, 27(20): 2357-2360.
17. Tumber MB, Dickersin K. Publication of clinical trials: accountability and accessibility. J Intern Med, 2004, 256(4): 271-283.
18. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Lancet, 2004, 364(9438): 911-912.
19. 邬兰, 田国祥, 王行环, 等. 临床试验的注册及注册平台比较分析. 中国循证心血管医学杂志, 2017, 9(2): 129-134.
20. Hasselblatt H, Dreier G, Antes G, et al. The German clinical trials register: challenges and chances of implementing a bilingual registry. J Evid Based Med, 2009, 2(1): 36-40.
21. Jiménez G, Pascual MA, Fors M, et al. The Cuban public registry of clinical trials: primary registry of World Health Organization. J Evid Based Med, 2011, 4(3): 161-164.
22. Wu T, Li Y, Liu G, et al. Chinese clinical trial registry: mission, responsibility and operation. J Evid Based Med, 2011, 4(3): 165-167.
23. Askie LM. Australian New Zealand clinical trials registry: history and growth. J Evid Based Med, 2011, 4(3): 185-187.
24. 李昕雪, 韩梅, 王禹毅, 等. 临床试验的国际注册及在美国临床试验注册平台注册的意义与方法. 中医杂志, 2013, 54(19): 1640-1643.
25. 梁晨. 对转型时期我国药品监管体制的宏观思考. 中国卫生政策研究, 2015, 8(4): 18-23.

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Comparison of drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, and completion

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