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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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. 隨機化臨床試驗結果分析和解釋的幾個問題. 中華醫學雜志, 2000, 80(6): 475-477.
11.	盧鵬飛, 廖星, 謝雁鳴, 等. 基于美國 ClinicalTrials.gov 分析中醫藥臨床試驗注冊特點. 中國中西醫結合雜志, 2015, 35(11): 1388-1392.
12.	吳泰相, 李幼平, 姚巡, 等. 實行臨床試驗注冊制度, 提高我國臨床研究質量. 中國循證醫學雜志, 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.	鄔蘭, 田國祥, 王行環, 等. 臨床試驗的注冊及注冊平臺比較分析. 中國循證心血管醫學雜志, 2017, 9(2): 129-134.
15.	嚴愷, 李佳, 孔艷婷, 等. ClinicalTrials.gov 建庫以來兒童臨床試驗注冊現況橫斷面調查. 中國循證兒科雜志, 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. 吳泰相, 李幼平, 卞兆祥, 等. 中醫藥臨床隨機對照試驗報告規范(征求意見稿). 中國循證醫學雜志, 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. 曹瑩瑩, 林能明, 方羅. 中國臨床試驗注冊中心在冊藥物臨床試驗分析. 中國藥房, 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. 隨機化臨床試驗結果分析和解釋的幾個問題. 中華醫學雜志, 2000, 80(6): 475-477.
11. 盧鵬飛, 廖星, 謝雁鳴, 等. 基于美國 ClinicalTrials.gov 分析中醫藥臨床試驗注冊特點. 中國中西醫結合雜志, 2015, 35(11): 1388-1392.
12. 吳泰相, 李幼平, 姚巡, 等. 實行臨床試驗注冊制度, 提高我國臨床研究質量. 中國循證醫學雜志, 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. 鄔蘭, 田國祥, 王行環, 等. 臨床試驗的注冊及注冊平臺比較分析. 中國循證心血管醫學雜志, 2017, 9(2): 129-134.
15. 嚴愷, 李佳, 孔艷婷, 等. ClinicalTrials.gov 建庫以來兒童臨床試驗注冊現況橫斷面調查. 中國循證兒科雜志, 2016, 11(1): 3-7.

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