Objective To investigate the domestic and abroad hypertension-related clinical trial registration and to analyze the registration of hypertension-related clinical researches in China.Methods Using hypertension as the keyword, we searched ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR) from January 2008 to December 2018. We analyzed the collected data on the distribution of registered clinical researches, annual trends, sample sizes, trial progress, research types, study designs, blind methods, clinical stages, the number of participating institutions, the leading institutions, etc.Results The total number of registered hypertension-related clinical trails was 4 991 all over the world, and 551 items were conducted in China. Most of the sample sizes of Chinese hypertension-related clinical trials were 100 to 999. The main types of trials were interventional studies (393 items, 71.32%), followed by observational studies (126 items, 22.87%). Randomized parallel control studies (300 items, 76.34%) were the key component of interventional studies, while cohort studies (61 items, 48.41%) were the chief component of observational studies. The main stages of clinical trials were stage Ⅲ (80 items) and stage Ⅳ (122 items). There were 369 domestic single-center clinical trials (66.97%), 89 domestic multi-center clinical trials (16.15%), and 93 international multi-center clinical trials (16.88%). Among the 93 international multi-center trials of hypertension, only 25 were led by China.Conclusions The number of Chinese hypertension-related clinical trial registrations increased year by year and then decreased slightly, but the amount of registrations is limited. The quantity and scale of multicenter clinical studies were not as good as America. China should strengthen the awareness of clinical research registration, strengthen the publicity and supervision of the registration of clinical researches by the department of science and management, improve the number of clinical trial registrations, make Chinese clinical researches more transparent, and strive to lead more international multi-center clinical trials.
Citation：
ZHANG Ting, LI Wanling, CHEN Lei. Analysis of hypertension-related clinical trial registration in China based on ClinicalTrials.gov and Chinese Clinical Trial Registry database. West China Medical Journal, 2019, 34(4): 419-424. doi: 10.7507/1002-0179.201901179
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Copyright © the editorial department of West China Medical Journal of West China Medical Publisher. All rights reserved
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- 1. Word Health Organization. Causes of Death. Geneva: World Health Organization, 2008. [2019-01-22]. http://www.who.int/healthinfo/global_burden_disease/cod_2008_sources_methods.pdf.
- 2. Word Health Organization. 高血压全球概要. 2013. (2013-02)[2019-01-22]. https://www.who.int/cardiovascular_diseases/publications/global_brief_hypertension/zh/.
- 3. 王洋, 雷燕. 美国临床试验数据库注册流程与填写要求. 中国中医药信息杂志, 2012, 19(7): 2-4.
- 4. 李宛凌, 陈蕾. 临床试验注册概述及其在神经病学领域的应用. 华西医学, 2018, 33(6): 758-761.
- 5. 吴泰相, 李幼平, 李静, 等. 临床试验的里程碑事件:全球临床试验注册制度建成运行. 中国循证医学杂志, 2007, 7(7): 479-480.
- 6. 吴泰相, 米娜瓦尔·阿不都, 郝园, 等. 中国临床试验注册 10 年: 现状与问题. 中国循证医学杂志, 2018, 18(6): 522-525.
- 7. 李佳, 严恺, 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.
- 8. 施芳红, 张在丽, 李浩. 国内外糖尿病临床研究注册和用药情况及中国现状分析. 药物流行病学杂志, 2018, 27(4): 277-280.
- 9. 晏小勇, 陈永法. 美国临床试验注册与结果公开制度研究. 中国新药杂志, 2011, 20(7): 577-581.
- 10. 国家食品药品监督管理局公布新修订的《药品注册管理办法》. 中国新药与临床杂志, 2007, 26(8): 638.
- 11. 吴泰相, 卞兆祥, 李幼平, 等. 临床试验原始数据透明化与共享:关于医学研究伦理的哲学命题及其对临床试验的意义. 中国循证医学杂志, 2018, 18(6): 538-542.
- 12. 王晓晖, 陈静, 李静, 等. 中国临床试验实施质量控制的发展与变革. 中国循证医学杂志, 2018, 18(8): 776-782.
- 13. 董冲亚, 阎小妍, 姚亮, 等. 规范多中心临床试验势在必行. 中国循证医学杂志, 2018, 18(7): 654-656.
- 14. 袁方. 我国开展国际多中心临床试验的现状及改进措施. 医药导报, 2007, 26(1): 100-102.
- 15. 孙梅, 张超逸, 陈玉文. 我国开展国际多中心药物临床试验现状分析. 中国新药杂志, 2016, 25(15): 1737-1740.
- 16. 钱翠红, 连桂玉. 外国制药企业在我国开展抗糖尿病药物临床试验的现状分析. 中国新药杂志, 2017, 26(17): 2014-2018.
