基于美国ClinicalTrials.gov分析中医药临床试验注册特点 : = Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov.(USA)
近10年,中医药临床试验在美国ClinicalTrials.gov注册的试验数量不断增多。为了解中医药临床试验注册特点,本研究全面检索美国ClinicalTrials.gov注册库,采用EXCEL表对纳入分析的临床试验逐条录入。最终纳入348个中医药临床试验,结果显示中国是中医药临床试验注册的主要国家,其次是美国;中医药临床试验以干预性研究、院校和医院主办、评价药品的安全性或(和)有效性为主;中医药干预性研究中,中国大陆主办、公司主办、招募中试验及多中心研究试验比例增加,中国香港、台湾主办、研究完成试验、研究状态不清楚试验、Ⅲ期临床试验及研究发表试验比例下降;中医药临床试验研究发表比例较低,试验注册信息缺失类型多、比例高。.
In recent 10 years,clinical trials of Chinese medicine and pharmacy(CMP) at ClinicalTrials.gov.(USA) are gradually increasing.In order to analyze features of CMP clinical register,ClinicalTrials.gov register database were comprehensively retrieved in this study.Included clinical trials were input one item after another using EXCEL.A final of 348 CMP clinical trials were included.Results showed that China occupied the first place in CMP clinical register,followed by USA.CMP clinical trials,sponsored mainly by colleges/universities and hospitals,mostly covered interventional studies on evaluating safety/effectiveness of CMP.The proportions of studies,sponsored by mainland China and companies,recruitment trials and multi-center clinical trials in interventional trials were increasing.The proportions of studies sponsored by Hong Kong and Taiwan,research completed trials,unclear research status,phaseⅢ clinical trials,and published research trials in interventional trials were decreasing.Published ratios of CMP clinical trials were quite low.There were more missing types and higher proportions in trial register information..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2015-11-20 2015 |
|---|---|
| Erschienen: |
2015-11-20 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2015 |
|---|---|
| Enthalten in: |
Zhong guo zhong xi yi jie he za zhi - (2015), 11 vom: 20. Nov., Seite 1388-1392 Original Letters: Enthalten in 中国中西医结合杂志 (DE-600)2993987-2 (DE-600)2993987-2 北京市 |
| 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: |
Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov.(USA) |
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| Beteiligte Personen: |
卢鹏飞 [VerfasserIn] |
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| Links: |
oversea.cnki.net [lizenzpflichtig] |
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| Themen: |
中医 |
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| Anmerkungen: |
Author info:LU Peng-fei;LIAO Xing;XIE Yan-ming;WANG Zhi-guo;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CAJ493860673 |
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| 520 | |a 近10年,中医药临床试验在美国ClinicalTrials.gov注册的试验数量不断增多。为了解中医药临床试验注册特点,本研究全面检索美国ClinicalTrials.gov注册库,采用EXCEL表对纳入分析的临床试验逐条录入。最终纳入348个中医药临床试验,结果显示中国是中医药临床试验注册的主要国家,其次是美国;中医药临床试验以干预性研究、院校和医院主办、评价药品的安全性或(和)有效性为主;中医药干预性研究中,中国大陆主办、公司主办、招募中试验及多中心研究试验比例增加,中国香港、台湾主办、研究完成试验、研究状态不清楚试验、Ⅲ期临床试验及研究发表试验比例下降;中医药临床试验研究发表比例较低,试验注册信息缺失类型多、比例高。 | ||
| 520 | |a In recent 10 years,clinical trials of Chinese medicine and pharmacy(CMP) at ClinicalTrials.gov.(USA) are gradually increasing.In order to analyze features of CMP clinical register,ClinicalTrials.gov register database were comprehensively retrieved in this study.Included clinical trials were input one item after another using EXCEL.A final of 348 CMP clinical trials were included.Results showed that China occupied the first place in CMP clinical register,followed by USA.CMP clinical trials,sponsored mainly by colleges/universities and hospitals,mostly covered interventional studies on evaluating safety/effectiveness of CMP.The proportions of studies,sponsored by mainland China and companies,recruitment trials and multi-center clinical trials in interventional trials were increasing.The proportions of studies sponsored by Hong Kong and Taiwan,research completed trials,unclear research status,phaseⅢ clinical trials,and published research trials in interventional trials were decreasing.Published ratios of CMP clinical trials were quite low.There were more missing types and higher proportions in trial register information. | ||
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