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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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.	陳君超. 從試驗注冊到結果公開進一步提高臨床試驗的透明化. 中國新藥雜志, 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.	鄔蘭, 田國祥, 王行環, 等. 臨床試驗的注冊及注冊平臺比較分析. 中國循證心血管醫學雜志, 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, 韓梅, 王禹毅, 等. 臨床試驗的國際注冊及在美國臨床試驗注冊平臺注冊的意義與方法. 中醫雜志, 2013, 54(19): 1640-1643.
25.	梁晨. 對轉型時期我國藥品監管體制的宏觀思考. 中國衛生政策研究, 2015, 8(4): 18-23.

1. 武陽豐, 方偉崗. 論我國醫科院校如何發展高水平臨床研究. 北京大學學報(醫學版), 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. 周江華, 董碧蓉. 通過推進注冊提升臨床試驗研究質量. 現代臨床醫學, 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. 吳泰相, 李幼平, 劉關鍵, 等. 中國臨床試驗注冊中心及中國循證醫學中心提高我國臨床試驗質量的策略和措施. 中國循證醫學雜志, 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. 陳君超. 從試驗注冊到結果公開進一步提高臨床試驗的透明化. 中國新藥雜志, 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. 鄔蘭, 田國祥, 王行環, 等. 臨床試驗的注冊及注冊平臺比較分析. 中國循證心血管醫學雜志, 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, 韓梅, 王禹毅, 等. 臨床試驗的國際注冊及在美國臨床試驗注冊平臺注冊的意義與方法. 中醫雜志, 2013, 54(19): 1640-1643.
25. 梁晨. 對轉型時期我國藥品監管體制的宏觀思考. 中國衛生政策研究, 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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