基于ClinicalTrials.gov和中国临床研究注册中心数据库分析中国高血压临床研究注册情况
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摘要
目的了解国内外高血压临床研究注册情况,分析中国高血压临床研究注册情况。方法通过检索2008年—2018年期间在美国ClinicalTrials.gov和中国临床研究注册中心(Chinese Clinical Trial Registry,ChiCTR)注册的高血压临床研究,分析中国注册高血压临床研究在区域分布、年度趋势、样本量、试验进展、研究类型、试验设计、盲法使用、临床分期、参与机构数量、牵头单位等方面的特点。结果两个数据库有高血压临床研究共4 991项,中国高血压临床研究共551项;中国高血压临床试验样本量以100～999例最多;试验类型以干预性研究为主(393项,71.32%),其次是观察性研究(126项,22.87%);干预性研究的研究模式以随机平行对照为主(300项,76.34%),观察性研究的试验模式以队列研究为主(61项,48.41%);临床试验分期以Ⅲ期(80项)和Ⅳ期(122项)为主;国内单中心临床试验有369项(66.97%),国内多中心临床试验89项(16.15%),国际多中心临床试验93项(16.88%);93项高血压国际多中心临床试验中,中国牵头仅25项。结论中国高血压临床试验年注册量逐年上升后又略有下降,注册数量依旧偏低,国际多中心临床研究数量与规模均与美国存在一定差距。我国应强化临床研究注册意识,加强科管职能部门对临床研究注册的宣传和管理力度,提高临床试验注册数量,使中国临床研究更透明规范,争取牵头更多国际多中心临床试验。
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 Clinical Trials.gov and Chinese Clinical Trial Registry(ChiCTR) from January 2008 to December2018. 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 s tudies, while cohort studies(61 items, 48.41%) were the chief component of observational studies. The main stages ofclinical 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.
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 Clinical Trials.gov and Chinese Clinical Trial Registry(ChiCTR) from January 2008 to December2018. 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 s tudies, while cohort studies(61 items, 48.41%) were the chief component of observational studies. The main stages ofclinical 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.
引文
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.
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.