Whole-process quality control of clinical trials: emphasis on registration and reporting_Chinese Journal of Evidence-Based Medicine

Authors：

 DU Liang ^1,2 , LI Youping ¹ , ZHANG Yonggang ^1,2

1. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. West China Periodical Press, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

DU Liang, Email: dul@cjebm.org.cn

Keywords：

Clinical trial; Clinical trial registration; Clinical trial transparency; Reporting guideline

DOI：

10.7507/1672-2531.201711020

Video：

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Citation： DU Liang, LI Youping, ZHANG Yonggang. Whole-process quality control of clinical trials: emphasis on registration and reporting. Chinese Journal of Evidence-Based Medicine, 2017, 17(11): 1241-1244. doi: 10.7507/1672-2531.201711020 Copy

1.	Bastian H, Glasziou P, Chalmers I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep up? PLoS Med, 2010, 7(9): e1000326.
2.	Viergever RF, Li K. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013. BMJ Open, 2015, 5(9): e008932.
3.	Steinbrook R. Registration of Clinical Trials. N Engl J Med, 2004, 351: 315-318.
4.	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.
5.	De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA, 2004, 292(11): 1363-1364.
6.	WHO. Statement of NY Workgroup. Available at: http:// www.who.int/ictrp/news/NYStatement.pdf.
7.	Ministerial Summit on Health Research. The Mexico Statement on Health Research. Available at: http://www.who.int/rpc/summit/ agenda/en/mexico_statement_on_health_research.pdf?ua=1.
8.	Taichman DB, Sahni P, Pinborg A, et al. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. JAMA, 2017, 317(24): 2491-2492.
9.	Wu T, Li Y, Bian Z, et al. Randomized trials published in some Chinese journals: how many are randomized? Trials, 2009, 10: 46.
10.	Woodhead M. 80% of China's clinical trial data are fraudulent, investigation finds. BMJ, 2016, 355: i5396.
11.	王香平, 李晓玲, 王育琴. 我国医院伦理委员会现状及国际认证分析. 医学与哲学, 2012, 33(4): 30-32.
12.	中共中央办公厅, 国务院办公厅. 关于深化审评审批制度改革鼓励药品医疗器械创新的意见. Available at: http://www. sda.gov.cn/WS01/CL1746/178283.html.
13.	Available at: www.equator-network.org/.
14.	Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276(8): 637-639.
15.	Chen Y, Yang K, Marušic A, et al. A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement. Ann Intern Med, 2017, 166(2): 128-132.
16.	Cheng CW, Wu TX, Shang HC, et al. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med, 2017, 167(2): W7-W20.

1. Bastian H, Glasziou P, Chalmers I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep up? PLoS Med, 2010, 7(9): e1000326.
2. Viergever RF, Li K. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013. BMJ Open, 2015, 5(9): e008932.
3. Steinbrook R. Registration of Clinical Trials. N Engl J Med, 2004, 351: 315-318.
4. 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.
5. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA, 2004, 292(11): 1363-1364.
6. WHO. Statement of NY Workgroup. Available at: http:// www.who.int/ictrp/news/NYStatement.pdf.
7. Ministerial Summit on Health Research. The Mexico Statement on Health Research. Available at: http://www.who.int/rpc/summit/ agenda/en/mexico_statement_on_health_research.pdf?ua=1.
8. Taichman DB, Sahni P, Pinborg A, et al. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. JAMA, 2017, 317(24): 2491-2492.
9. Wu T, Li Y, Bian Z, et al. Randomized trials published in some Chinese journals: how many are randomized? Trials, 2009, 10: 46.
10. Woodhead M. 80% of China's clinical trial data are fraudulent, investigation finds. BMJ, 2016, 355: i5396.
11. 王香平, 李晓玲, 王育琴. 我国医院伦理委员会现状及国际认证分析. 医学与哲学, 2012, 33(4): 30-32.
12. 中共中央办公厅, 国务院办公厅. 关于深化审评审批制度改革鼓励药品医疗器械创新的意见. Available at: http://www. sda.gov.cn/WS01/CL1746/178283.html.
13. Available at: www.equator-network.org/.
14. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276(8): 637-639.
15. Chen Y, Yang K, Marušic A, et al. A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement. Ann Intern Med, 2017, 166(2): 128-132.
16. Cheng CW, Wu TX, Shang HC, et al. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med, 2017, 167(2): W7-W20.

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