Assessment of Registration Quality of Trials Sponsored by China_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Xuemei ^1,2 ,  LI Youping ² , YU Xinting ³ , FENG Juan ³ , ZHONG Xushu ³ , YANG Xiaoyan ² , LI Jing ²

1. Editorial Board of Chinese Journal of Evidence-Based Medicine, Periodical Press of West China Hospital, Sichuan University, Chengdu 610041, China;2. Chinese Evidence-Based Medicine/ Cochrane Center, Chengdu 610041, China;3. West China School of Medicine, Sichuan University, Chengdu 610041, China;

Corresponding author：

LI Youping, Email: yzmylab@hotmail.com

Keywords：

Trial sponsored by China; Trial registration; Registration quality; WHO trial registration data set

DOI：

10.7507/1672-2531.20090037

Video：

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Objective 　To evaluate the quality of the registration information for trials sponsored by China registered in the WHO International Clinical Trial Registration Platform (ICTRP) primary registries or other registries that meet the requirements of the International Committee Medical Journal Editor (ICMJE).
Methods 　We assessed the registration information for trials registered in the 9 WHO primary registries and one other registry that met the requirements of ICJME as of 15 October 2008. We analyzed the trial registration data set in each registry and assessed the registration quality against the WHO Trial Registration Data Set (TRDS). We also evaluated the quality of the information in the Source(s) of Monetary or Material Support section, using a specially prepared scale.
Results 　The entries in four registries met the 20 items of the WHO TRDS. These were the Chinese Clinical Trial Registration Center (ChiCR), Australian New Zealand Clinical Trials Registry (NZCTR), Clinical Trials Registry – India (CTRI), and Sri Lanka Clinical Trials Registry (SLCTR). Registration quality varied among the different registries. For example, using the Scale of TRDS, the NZCTR scoreda median of 19 points, ChiCTR (median = 18 points), ISRCTN.org (median = 17 points), and Clinical trials.org (median = 12 points). The data on monetary or material support for ChiCTR and ISRCTN.org were relatively complete and the score on our Scale for the Completeness of Funding Registration Quality ranged from ChiCTR (median = 7 points), ISRCTN.org (median = 6 points), NZCTR (median = 3 points) to clinicaltrials.gov (median = 2 points).
Conclusion 　 Further improvements are needed in both the quantity and quality of trial registration. This could be achieved by full completion of the 20 items of the WHO TRDS. Future research should assess ways to ensure the quality and scope of research registration and the role of mandatory registration of funded research.

Citation： LIU Xuemei,LI Youping,YU Xinting,FENG Juan,ZHONG Xushu,YANG Xiaoyan,LI Jing. Assessment of Registration Quality of Trials Sponsored by China. Chinese Journal of Evidence-Based Medicine, 2009, 09(2): 178-186. doi: 10.7507/1672-2531.20090037 Copy

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17.	Ghersi D, Pang T. From Mexico to Mail: four years in the history of clinical trial registration. Journal of Evidence-Based Medicine, 2009, 2(1): 正在印刷.

1. Krleza-Jerić K, Chan AW, Dickersin K, et al. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ, 2005, 330(7497): 956-958.
2. Steinbrook R. Public Registration of Clinical Trials. N Engl J Med, 2004, 351(4): 315-317.
3. Godlee F. An international standard for disclosure of clinical trial information. BMJ, 2006, 332: 1107-1108.
4. Kimball AB, Weinstock MA, Massachusetts B Island PR. Mandatory registration of clinical trials: A major step forward for evidencebased medicine. J Am Acad Dermatol, 2005, 52(5): 890-892.
5. Krleza-Jerić K. Cl incial trial registration: the differing views of industry, the WHO, and the Ottawa group. Plos Medicine, 2005, 2(11): 1093-1097.
6. World Health Organization. Internation Clinical Trials Registry Platform.Accessed at http://www.who.int/ictrp/about/details/en/ index.html on 22 December, 2008.
7. 国家食品药品监督管理总局. 数据查询. Accessed at http://app1. sfda.gov.cn/datasearch/face3/dir.html 22 December, 2008.
8. 吴广恩, 王英华, 夏志平. 科技期刊表格必须自明. 编辑学报, 2005, 17(2): 107-109.
9. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [Editorial]. Ann Intern Med, 2004, 141: 477-478.
10. International Committee of Medical Journal Editors. Is This Clinical Trial Fully Registered? A Statement from the International Committee of Medical Journal Editors. Ann Intern Med, 2005, 143: 146-148.
11. Laine C, Horton R, DeAngelis CD, et al. Clinical Trial Registration Looking Back and Moving Ahead. Lancet, 2007, 369(9577): 1909-1011.
12. 吴泰相, 李幼平, 姚巡, 等. 实行临床试验注册制度, 提高我国临床研究质量. 中国循证医学杂志, 2006, 6(3): 153-156.
13. 孙站成, 傅裕贵, 许炎生. 关于国家自然科学基金资助项目建档工作的几点思考. 中国科学基金, 2008, 22(6): 364-366.
14. 国家自然科学基金委员会. 国家自然科学基金2007年度经费概况. Accessed at http://www.nsfc.gov.cn/nsfc/cen/ndbg/2007ndbg/ index.htm 0n 26 December 2008.
15. 刘雪梅, 李幼平, 吴泰相, 等. 基金资助的中国临床试验注册情况调查. 中国循证医学杂志, 2008, 8(5): 305-311.
16. 张鸣明, 李幼平, 段玉蓉, 等. 抓住机遇, 共迎全球化证据时代的到来. 中国循证医学杂志, 2008, 8(11): 941-942.
17. Ghersi D, Pang T. From Mexico to Mail: four years in the history of clinical trial registration. Journal of Evidence-Based Medicine, 2009, 2(1): 正在印刷.

Chinese Journal of Evidence-Based Medicine

Assessment of Registration Quality of Trials Sponsored by China

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