A registration analysis of hypertension-related clinical trials on Chinese Clinical Trial Registry_Chinese Journal of Evidence-Based Medicine

Authors：

SU Yanling ¹ , QUAN Liuliu ² , YANG Ziyu ¹ ,  LIAO Xiaoyang ¹ , LI Zhichao ³

1. International Medical Center, West China Hospital of Sichuan University, Chengdu, 610041, P.R.China;
2. West China School of Medicine, Sichuan University, Chengdu, 610041, P.R.China;
3. Day Surgery Center, West China Hospital of Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

LIAO Xiaoyang, Email: 625880796@qq.com

Keywords：

Hypertension; Clinical trials; Chinese Clinical Trial Registry

DOI：

10.7507/1672-2531.201807122

Video：

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ObjectivesTo analyze the metrological characteristics of hypertension-related clinical trials registered on Chinese Clinical Trial Registry (ChiCTR), and discuss the characteristics and developmental trends of hypertension clinical trials registration in China.MethodsChiCTR were searched to collect hypertension-related clinical trials from inception to March 25^th, 2018. The characteristics of registered trials were analyzed.ResultsA total of 135 registered trials were included, in which the trials from Beijing, Guangdong, Jiangsu, Chongqing and Shanghai accounted for 55.5%. 115 trials were pre-registered. The top three funding sources were from finance (32, 23.7%), self-financing (25, 18.5%) and hospital (20, 14.8%), respectively. Of all 79 randomized controlled trials, 55 were blank/missing in the entry of blinding method.ConclusionsThe number of hypertension-related clinical trials in ChiCTR tends to increase, however there are large regional disparities and incomplete, non-standardiazed information in the registration of clinical trials. The relevant departments should increase the publicity on the registration of clinical trials, raise the awareness of registration, and promote the development and registration of high quality clinical trials.

Citation： SU Yanling, QUAN Liuliu, YANG Ziyu, LIAO Xiaoyang, LI Zhichao. A registration analysis of hypertension-related clinical trials on Chinese Clinical Trial Registry. Chinese Journal of Evidence-Based Medicine, 2018, 18(10): 1114-1117. doi: 10.7507/1672-2531.201807122 Copy

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7.	Saito H, Gill CJ. How frequently do the results from completed US clinical trials enter the public domain?-A statistical analysis of the ClinicalTrials.gov database. PLoS One, 2014, 9(7): e101826.
8.	Ross JS, Mulvey GK, Hines EM, et al. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med, 2009, 6(9): e1000144.
9.	Sniderman AD, LaChapelle KJ, Rachon NA, et al. The necessity for clinical reasoning in the era of evidence-based medicine. Mayo Clin Proc, 2013, 88(10): 1108-1114.
10.	詹思延. 随机化临床试验结果分析和解释的几个问题. 中华医学杂志, 2000, 80(6): 475-477.
11.	卢鹏飞, 廖星, 谢雁鸣, 等. 基于美国 ClinicalTrials.gov 分析中医药临床试验注册特点. 中国中西医结合杂志, 2015, 35(11): 1388-1392.
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.	Zarin DA, Tse T, Williams RJ, et al. Trial Reporting in ClinicalTrials.gov - The Final Rule. N Engl J Med, 2016, 375(20): 1998-2004.
14.	邬兰, 田国祥, 王行环, 等. 临床试验的注册及注册平台比较分析. 中国循证心血管医学杂志, 2017, 9(2): 129-134.
15.	严恺, 李佳, 孔艳婷, 等. ClinicalTrials.gov 建库以来儿童临床试验注册现况横断面调查. 中国循证儿科杂志, 2016, 11(1): 3-7.

1. WHO. Causes of Death. Geneva: World Health Organization, 2008. Available at: http://www.who.int/healthinfo/global_burden_disease/cod_2008_sources_methods.pdf.
2. Lim SS, Vos T, Flaxman AD, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet, 2012, 380(9859): 2224-2260.
3. Lackland DT, Woolson RF. Clinical hypertension research tools: the randomized controlled clinical trial. J Clin Hypertens (Greenwich), 2006, 8(6): 427-431.
4. 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.
5. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Arch Otolaryngol Head Neck Surg, 2005, 131(6): 479-480.
6. 曹莹莹, 林能明, 方罗. 中国临床试验注册中心在册药物临床试验分析. 中国药房, 2012, (41): 3858-3860.
7. Saito H, Gill CJ. How frequently do the results from completed US clinical trials enter the public domain?-A statistical analysis of the ClinicalTrials.gov database. PLoS One, 2014, 9(7): e101826.
8. Ross JS, Mulvey GK, Hines EM, et al. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med, 2009, 6(9): e1000144.
9. Sniderman AD, LaChapelle KJ, Rachon NA, et al. The necessity for clinical reasoning in the era of evidence-based medicine. Mayo Clin Proc, 2013, 88(10): 1108-1114.
10. 詹思延. 随机化临床试验结果分析和解释的几个问题. 中华医学杂志, 2000, 80(6): 475-477.
11. 卢鹏飞, 廖星, 谢雁鸣, 等. 基于美国 ClinicalTrials.gov 分析中医药临床试验注册特点. 中国中西医结合杂志, 2015, 35(11): 1388-1392.
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. Zarin DA, Tse T, Williams RJ, et al. Trial Reporting in ClinicalTrials.gov - The Final Rule. N Engl J Med, 2016, 375(20): 1998-2004.
14. 邬兰, 田国祥, 王行环, 等. 临床试验的注册及注册平台比较分析. 中国循证心血管医学杂志, 2017, 9(2): 129-134.
15. 严恺, 李佳, 孔艳婷, 等. ClinicalTrials.gov 建库以来儿童临床试验注册现况横断面调查. 中国循证儿科杂志, 2016, 11(1): 3-7.

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