Changing face: from the publication of CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration to changing of clinical trials in China_Chinese Journal of Evidence-Based Medicine

Authors：

WU Taixiang ¹ , BIAN Zhaoxiang ² , SHANG Hongcai ³ ,  LI Youping ¹

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hongkong, 999077, P.R.China;
3. Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;

Corresponding author：

LI Youping, Email: yzmylab@hotmail.com

Keywords：

CONSORT; Chinese herbal medicine formulas; Clinical trial; Reporting guideline; Data sharing

DOI：

10.7507/1672-2531.201707102

Video：

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Citation： WU Taixiang, BIAN Zhaoxiang, SHANG Hongcai, LI Youping. Changing face: from the publication of CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration to changing of clinical trials in China. Chinese Journal of Evidence-Based Medicine, 2017, 17(9): 993-998. doi: 10.7507/1672-2531.201707102 Copy

1.	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.
2.	郑颂华, 吴泰相, 商洪才, 等. 中药复方临床随机对照试验报告规范 2017: CONSORT 声明的扩展、说明与详述. Ann Intern Med, 2017, 167(2): W21-W34.
3.	鄭頌華, 吳泰相, 商洪才, 等. 中藥複方臨床隨機對照試驗報告規範 2017: CONSORT 聲明的擴展、說明與詳述. Ann Intern Med, 2017, 167(2): W7-W20.
4.	MacPherson H, Altman DG, Hammerschlag R, et al. STRICTA Revision Group: Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med, 2010, 7(6): e1000261.
5.	吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范 (征求意见稿). 中国循证医学杂志, 2007, 7(8): 601-605.
6.	吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范 (征求意见稿). 中国循证医学杂志, 2007, 7(9): 625-630.
7.	卞兆祥, David Moher, 李幼平, 等. Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine. 中西医结合学报, 2008, 6(8): 771-775.
8.	郑颂华, 卞兆祥, 李幼平, 等. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials. 中西医结合学报, 2008, 6(9): 881-886.
9.	Bian Z, Liu B, Moher D, et al. Consolidated standards of reporting trials (CONSORT) for traditional Chinese medicine: current situation and future development. Front Med, 2011, 5(2): 171-177.
10.	卞兆祥, David Moher, 李幼平, 等. Precise reporting of traditional Chinese medicine interventions in randomized controlled trials. 中西医结合学报, 2008, 6(7): 661-667.
11.	李幼平, 吴泰相, 刘关键, 等. 中国循证医学中心促进中医药现代化的策略. 中国循证医学杂志, 2007, 7(3): 159-161.
12.	吴泰相, 李幼平, 李静, 等. 中国临床试验注册和发表机制及实施说明. 中国循证医学杂志, 2006, 6(6): 395-396.
13.	吴泰相, 李幼平, 卞兆祥, 等. 实施临床试验报告规范, 提高临床试验透明度. 中国循证医学杂志, 2007, 7(8): 551-554.
14.	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.
15.	Jeffrey M, Drazen, David P. et al. Editors: The changing face of clinical trials. N Engl J Med, 2016, 374: 22.
16.	Woodcock J, Ware JH, Miller PW, et al. Clinical trials series. N Engl J Med, 2016, 374: 2167.
17.	DeMets DL, Ellenberg SS. Data monitoring committees-expect the unexpected. N Engl J Med, 2016, 375(14): 1365-1371.
18.	Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica, 2015, 38(6): 506-514.
19.	Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
20.	中国国家食品药品监督管理总局. 临床试验数据管理工作技术指南. Available at: http://www.sda.gov.cn/WS01/CL0087/ 160961.html.
21.	Zarin DA, Tse T. Sharing individual participant data (IPD) within the context of the trial reporting system (TRS). PLoS Med, 13(1): e1001946.
22.	Taichman DB, Sahni P, Pinborg A, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. Lancet, 2017, 389(10086): 12-14.
23.	Goldacre B. The WHO joint statement from funders on trials transparency. This new statement from non-industry funders is a model of best practice. BMJ, 2017, 357: 2816.
24.	Hopkins C, Sydes M, Murray G, et al. UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns. J Clin Epidemiol, 2016, 70: 17-25.
25.	新药临床数据造假, 政策逼出的潜规则. Available at: http:// news.163.com/15/0821/07/B1HCKC0O00014JHT.html.
26.	新药临床试验数据为何造假成风. Available at: http://view. news.qq.com/original/intouchtoday/n3273.html.
27.	八成新药数据涉假曝医药生态恶劣. Available at: http://www. jjckb.cn/2016-09/09/c_135673951.htm.
28.	80% of Data in Chinese clinical trials have been fabricated. Available at: http://www.sciencealert.com/80-of-the-data-in-chinese-clinical-trial-is-fabricated.
29.	中国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(征求意见稿). Available at: http:// www.sda.gov.cn/WS01/CL0778/171506.html.
30.	中华人民共和国最高人民法院. 最高法审委会全体会议审议并原则通过《最高人民法院、最高人民检察院关于办理药品、医疗器械注册申请数据造假刑事案件适用法律若干问题的解释》. Available at: http://www.court.gov.cn/fabu-xiangqing-39752.html.

1. 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.
2. 郑颂华, 吴泰相, 商洪才, 等. 中药复方临床随机对照试验报告规范 2017: CONSORT 声明的扩展、说明与详述. Ann Intern Med, 2017, 167(2): W21-W34.
3. 鄭頌華, 吳泰相, 商洪才, 等. 中藥複方臨床隨機對照試驗報告規範 2017: CONSORT 聲明的擴展、說明與詳述. Ann Intern Med, 2017, 167(2): W7-W20.
4. MacPherson H, Altman DG, Hammerschlag R, et al. STRICTA Revision Group: Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med, 2010, 7(6): e1000261.
5. 吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范 (征求意见稿). 中国循证医学杂志, 2007, 7(8): 601-605.
6. 吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范 (征求意见稿). 中国循证医学杂志, 2007, 7(9): 625-630.
7. 卞兆祥, David Moher, 李幼平, 等. Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine. 中西医结合学报, 2008, 6(8): 771-775.
8. 郑颂华, 卞兆祥, 李幼平, 等. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials. 中西医结合学报, 2008, 6(9): 881-886.
9. Bian Z, Liu B, Moher D, et al. Consolidated standards of reporting trials (CONSORT) for traditional Chinese medicine: current situation and future development. Front Med, 2011, 5(2): 171-177.
10. 卞兆祥, David Moher, 李幼平, 等. Precise reporting of traditional Chinese medicine interventions in randomized controlled trials. 中西医结合学报, 2008, 6(7): 661-667.
11. 李幼平, 吴泰相, 刘关键, 等. 中国循证医学中心促进中医药现代化的策略. 中国循证医学杂志, 2007, 7(3): 159-161.
12. 吴泰相, 李幼平, 李静, 等. 中国临床试验注册和发表机制及实施说明. 中国循证医学杂志, 2006, 6(6): 395-396.
13. 吴泰相, 李幼平, 卞兆祥, 等. 实施临床试验报告规范, 提高临床试验透明度. 中国循证医学杂志, 2007, 7(8): 551-554.
14. 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.
15. Jeffrey M, Drazen, David P. et al. Editors: The changing face of clinical trials. N Engl J Med, 2016, 374: 22.
16. Woodcock J, Ware JH, Miller PW, et al. Clinical trials series. N Engl J Med, 2016, 374: 2167.
17. DeMets DL, Ellenberg SS. Data monitoring committees-expect the unexpected. N Engl J Med, 2016, 375(14): 1365-1371.
18. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica, 2015, 38(6): 506-514.
19. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
20. 中国国家食品药品监督管理总局. 临床试验数据管理工作技术指南. Available at: http://www.sda.gov.cn/WS01/CL0087/ 160961.html.
21. Zarin DA, Tse T. Sharing individual participant data (IPD) within the context of the trial reporting system (TRS). PLoS Med, 13(1): e1001946.
22. Taichman DB, Sahni P, Pinborg A, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. Lancet, 2017, 389(10086): 12-14.
23. Goldacre B. The WHO joint statement from funders on trials transparency. This new statement from non-industry funders is a model of best practice. BMJ, 2017, 357: 2816.
24. Hopkins C, Sydes M, Murray G, et al. UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns. J Clin Epidemiol, 2016, 70: 17-25.
25. 新药临床数据造假, 政策逼出的潜规则. Available at: http:// news.163.com/15/0821/07/B1HCKC0O00014JHT.html.
26. 新药临床试验数据为何造假成风. Available at: http://view. news.qq.com/original/intouchtoday/n3273.html.
27. 八成新药数据涉假曝医药生态恶劣. Available at: http://www. jjckb.cn/2016-09/09/c_135673951.htm.
28. 80% of Data in Chinese clinical trials have been fabricated. Available at: http://www.sciencealert.com/80-of-the-data-in-chinese-clinical-trial-is-fabricated.
29. 中国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(征求意见稿). Available at: http:// www.sda.gov.cn/WS01/CL0778/171506.html.
30. 中华人民共和国最高人民法院. 最高法审委会全体会议审议并原则通过《最高人民法院、最高人民检察院关于办理药品、医疗器械注册申请数据造假刑事案件适用法律若干问题的解释》. Available at: http://www.court.gov.cn/fabu-xiangqing-39752.html.

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Changing face: from the publication of CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration to changing of clinical trials in China

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