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 : = Analysis of hypertension-related clinical trial registration in China based on ClinicalTrials.gov and Chinese Clinical Trial Registry database
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..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019-04-16 14:54 2019 |
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| Erschienen: |
2019-04-16 14:54 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2019 |
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| Enthalten in: |
Hua xi yi xue - (2019), 04 vom: 16 14:54. Apr., Seite 419-424 Original Letters: Enthalten in 华西医学 (DE-600)2990062-1 (DE-600)2990062-1 四川省成都市 |
| Reihe: |
China Academic Journals (CAJ), E, 医药卫生科技 = Medicine & Public Health |
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| Sprache: |
Chinesisch |
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| Weiterer Titel: |
Analysis of hypertension-related clinical trial registration in China based on ClinicalTrials.gov and Chinese Clinical Trial Registry database |
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| Beteiligte Personen: |
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| Links: |
oversea.cnki.net [lizenzpflichtig] |
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| Anmerkungen: |
Author info:ZHANG Ting;LI Wanling;CHEN Lei;Department of Clinical Research Management, West China Hospital, Sichuan University;Department of Cardiology, West China Hospital, Sichuan University;Department of Neurology, West China Hospital, Sichuan University |
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| PPN (Katalog-ID): |
CAJ630734208 |
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| 245 | 1 | 0 | |a 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 |b = Analysis of hypertension-related clinical trial registration in China based on ClinicalTrials.gov and Chinese Clinical Trial Registry database |
| 246 | 3 | 1 | |a Analysis of hypertension-related clinical trial registration in China based on ClinicalTrials.gov and Chinese Clinical Trial Registry database |
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| 500 | |a Author info:ZHANG Ting;LI Wanling;CHEN Lei;Department of Clinical Research Management, West China Hospital, Sichuan University;Department of Cardiology, West China Hospital, Sichuan University;Department of Neurology, West China Hospital, Sichuan University | ||
| 520 | |a 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。 | ||
| 520 | |a 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. | ||
| 610 | 2 | 4 | |a 四川大学华西医院临床研究管理部 |
| 610 | 2 | 4 | |a 四川大学华西医院心脏内科 |
| 610 | 2 | 4 | |a 四川大学华西医院神经内科 |
| 650 | 4 | |a 心脏、血管（循环系）疾病 | |
| 650 | 4 | |a 内科学 | |
| 650 | 4 | |a 医药、卫生 | |
| 650 | 4 | |a Cardiovascular System Disease | |
| 650 | 4 | |a 医药卫生科技 | |
| 650 | 4 | |a Medicine & Public Health | |
| 650 | 4 | |a ClinicalTrials.gov | |
| 650 | 4 | |a 中国临床研究注册中心 | |
| 650 | 4 | |a 高血压 | |
| 650 | 4 | |a 临床研究 | |
| 650 | 4 | |a 注册情况 | |
| 650 | 4 | |a Clinical Trials.gov | |
| 650 | 4 | |a Chinese Clinical Trial Registry(ChiCTR) | |
| 650 | 4 | |a Hypertension | |
| 650 | 4 | |a Clinical research | |
| 650 | 4 | |a Registration | |
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