The status of registrations, ethical reviews and informed consent forms in RCTs of high impact factor Chinese medical journals_Chinese Journal of Evidence-Based Medicine

Authors：

ZHAO Hongjie ¹ ,  ZHANG Junhua ¹ , GUO Liping ² , YANG Fengwen ¹ , ZHANG Mingyan ¹ , LI Yue ¹ , WANG Hucheng ¹ , ZHANG Lishuang ¹ , JIN Xinyao ¹

1. Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;
2. Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;

Corresponding author：

ZHANG Junhua, Email: zjhtcm@foxmail.com

Keywords：

RCT; Registration; Ethical review; Informed consent; Reporting quality

DOI：

10.7507/1672-2531.201802027

Video：

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ObjectivesTo investigate the status of clinical trial registrations (CTRs), ethical reviews (ERs) and informed consent forms (ICFs) of randomized controlled trials (RCTs), which were published in the top 20 journals included by Chinese Science Citation Database (CSCD), and evaluate the methodological quality of RCTs.MethodsWe selected top 20 high impact factor Chinese medical journals indexed by CSCD, the RCTs published between 2016 and 2017 were searched. The CTR, ER and ICFs for all RCTs were analyzed.ResultsA total of 395 RCTs were included for data analysis. Nineteen RCTs (4.8%) reported the information of registration. For the 4 traditional Chinese medicine journals, only 4 (1.9%) of 207 RCTs reported the registered information. For the 16 western medical journals, only 15 (8%) of 188 RCTs reported the registered information. There were 185 RCTs (46.8%) which reported the information of ethical review. Among them, 66 RCTs (31.9%) were published in traditional Chinese medical journals and 119 RCTs (63.3%) were published in western medical journals. There were 253 RCTs (64.1%) which reported the information of informed consent. Among them, 154 RCTs (74.4%) were published in Chinese medical journals and 199 RCTs (52.7%) were in western medical journals. In terms of methodology, approximately 299 RCTs (75.7%) reported the type of randomization where 60 RCTs (15.2%) reported the information of allocation concealment and 38 RCTs (59.6%) reported blinding.ConclusionsThe proportion of RCTs registration, ethical review and informed consent is still low and the methodological quality of the studies require to be improved. Therefore, it is necessary to strengthen the training of clinical trial methodology.

Citation： ZHAO Hongjie, ZHANG Junhua, GUO Liping, YANG Fengwen, ZHANG Mingyan, LI Yue, WANG Hucheng, ZHANG Lishuang, JIN Xinyao. The status of registrations, ethical reviews and informed consent forms in RCTs of high impact factor Chinese medical journals. Chinese Journal of Evidence-Based Medicine, 2018, 18(7): 735-739. doi: 10.7507/1672-2531.201802027 Copy

1.	General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent, 2014, 81(3): 14-18.
2.	Tonks A. Registering clinical trials. BMJ, 1999, 319(7224): 1565-1568.
3.	International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication (2010-04). Available at: http://www.icmje.org/urm-full.pdf.
4.	吴泰相, 李幼平, 刘关键, 等. 临床试验注册制度与循证医学. 中国循证医学杂志, 2007, 7(4): 239-243.
5.	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.
6.	Logvinov I. Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act. Contemp Clin Trials, 2014, 37(2): 219-224.
7.	Tharyan P, Ghersi D. Registering clinical trials in India: a scientific and ethical imperative. Natl Med J India, 2008, 21(1): 31-34.
8.	Huser V, Cimino JJ. Evaluating adherence to the international committee of medical journal editors' policy of mandatory, timely clinical trial registration. J Am Med Inform Assoc, 2013, 20(e1): e169-e174.
9.	vande Wetering FT, Scholten RJ, Haring T, et al. Trial registration numbers are underreported in biomedical publications. PLoS One, 2012, 7(11): e49599.
10.	Pinto RZ, Elkins MR, Moseley AM, et al. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials. Phys Ther, 2013, 93(3): 299-309.
11.	Hooft L, Korevaar DA, Molenaar N, et al. Endorsement of ICMJE's clinical trial registration policy: a survey among journal editors. Neth J Med, 2014, 72(7): 349-355.
12.	Mathieu S, Chan AW, Ravaud P. Use of trial register information during the peer review process. PLoS One, 2013, 8(4): e59910.
13.	David Moher, Sally Hopewell, Kenneth F Schulz, 等. CONSORT 2010说明与详述: 报告平行对照随机临床试验指南的更新. 中西医结合学报, 2010, 8(8): 701-741.
14.	张明妍, 杨丰文, 李越, 等. 《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究. 中国循证医学杂志, 2017, 17(3): 357-363.
15.	田冬霞, 张金钟, 侯军儒. 中国伦理委员会运作现状的一个缩影-天津市三级医院伦理委员会的调查与分析. 中国医学伦理学, 2008, 21(1): 44-47.
16.	吴晓瑞, 李义庭, 赵学志, 等. 北京地区机构伦理审查委员会现状的调查分析. 医学与哲学, 2010, 31(5): 11-13.
17.	周吉银, 邓璠, 刘丹, 等. 我国医学伦理委员会存在的问题及建议. 中国临床药理学杂志, 2017, 33(4): 365-368.

1. General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent, 2014, 81(3): 14-18.
2. Tonks A. Registering clinical trials. BMJ, 1999, 319(7224): 1565-1568.
3. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication (2010-04). Available at: http://www.icmje.org/urm-full.pdf.
4. 吴泰相, 李幼平, 刘关键, 等. 临床试验注册制度与循证医学. 中国循证医学杂志, 2007, 7(4): 239-243.
5. 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.
6. Logvinov I. Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act. Contemp Clin Trials, 2014, 37(2): 219-224.
7. Tharyan P, Ghersi D. Registering clinical trials in India: a scientific and ethical imperative. Natl Med J India, 2008, 21(1): 31-34.
8. Huser V, Cimino JJ. Evaluating adherence to the international committee of medical journal editors' policy of mandatory, timely clinical trial registration. J Am Med Inform Assoc, 2013, 20(e1): e169-e174.
9. vande Wetering FT, Scholten RJ, Haring T, et al. Trial registration numbers are underreported in biomedical publications. PLoS One, 2012, 7(11): e49599.
10. Pinto RZ, Elkins MR, Moseley AM, et al. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials. Phys Ther, 2013, 93(3): 299-309.
11. Hooft L, Korevaar DA, Molenaar N, et al. Endorsement of ICMJE's clinical trial registration policy: a survey among journal editors. Neth J Med, 2014, 72(7): 349-355.
12. Mathieu S, Chan AW, Ravaud P. Use of trial register information during the peer review process. PLoS One, 2013, 8(4): e59910.
13. David Moher, Sally Hopewell, Kenneth F Schulz, 等. CONSORT 2010说明与详述: 报告平行对照随机临床试验指南的更新. 中西医结合学报, 2010, 8(8): 701-741.
14. 张明妍, 杨丰文, 李越, 等. 《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究. 中国循证医学杂志, 2017, 17(3): 357-363.
15. 田冬霞, 张金钟, 侯军儒. 中国伦理委员会运作现状的一个缩影-天津市三级医院伦理委员会的调查与分析. 中国医学伦理学, 2008, 21(1): 44-47.
16. 吴晓瑞, 李义庭, 赵学志, 等. 北京地区机构伦理审查委员会现状的调查分析. 医学与哲学, 2010, 31(5): 11-13.
17. 周吉银, 邓璠, 刘丹, 等. 我国医学伦理委员会存在的问题及建议. 中国临床药理学杂志, 2017, 33(4): 365-368.

Chinese Journal of Evidence-Based Medicine

The status of registrations, ethical reviews and informed consent forms in RCTs of high impact factor Chinese medical journals

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