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中国循证儿科杂志

中国循证儿科杂志 ›› 2016, Vol. 11 ›› Issue (1): 3-7.

• 论著 • 上一篇    下一篇

ClinicalTrials.gov建库以来儿童临床试验注册现况横断面调查

李佳1,6  严恺2,3,6  孔艳婷2,3 叶晓峰2,4 葛萌萌2,3 张崇凡5   

  1. 1 中华医学会 北京，100710；2 复旦大学附属儿科医院新生儿科 上海，201102；3 复旦大学附属儿科医院新生儿疾病卫生部重点实验室 上海，201102；4 福建省妇幼保健院 福州，350001；5 《中国循证儿科杂志》编辑部 上海，201102；6共同第一作者
  • 收稿日期:2016-02-23 修回日期:2016-02-23 出版日期:2016-02-05 发布日期:2016-02-05
  • 通讯作者: 张崇凡

A cross-sectional study of children clinical trials registration in the world based on ClinicalTrials.gov establishment

LI Jia1,6, YAN Kai2,3,6, KONG Yan-ting2,3, YE Xiao-feng2,4, GE Meng-meng2,3, ZHANG Chong-fan5   

  1. 1 Chinese Medical Association,Beijing 100710; 2 Department of Neonatology, Children's Hospital of Fudan University, Shanghai 201102; 3 Key Laboratory of Neonatal Diseases,Ministry of Health,Children's Hospital of Fudan University,Shanghai 201102;4 Fujian Maternity and Child Health Hospital,Fuzhou 350001;5 Chinese Journal of Evdience-Based Pediatrics,Shanghai 201102,China;6 Co-first author)
  • Received:2016-02-23 Revised:2016-02-23 Online:2016-02-05 Published:2016-02-05
  • Contact: ZHANG Chong-fan

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摘要：

目的 了解儿童临床试验在ClinicalTrials.gov的注册情况。方法 利用ClinicalTrials.gov数据库高级检索功能，检索儿童临床试验注册数量；确定地区，获得不同地区间的儿童临床试验注册数量；根据不同人群、研究状态与研究类型，对注册数量行分层分析。结果 截至2015年12月31日，ClinicalTrials.gov已注册儿童临床试验43 349项。美洲占53.8%、欧洲占21.27%、亚洲占14.5%，大洋洲占2.30%，非洲占4.2%。儿童临床试验注册前5位的国家为美国、加拿大、中国、法国和英国，中国大陆列第9位。发达国家儿童注册数量与GDP（美元）相关系数发达国家为0.92，发展中国家为0.62。美国的准备、纳入、在研和完成项目比例为1∶12∶5.5∶26.5，中国大陆比例为1∶8.6∶1.6∶8。观察性和干预性研究比例大致为1∶3。中国大陆儿童临床试验注册数量位居前5位的省市为北京、上海、广东、江苏和浙江，上述5省市占中国大陆儿童临床试验注册总数的95.4%（1 151/1 207）。结论 中国儿童临床试验注册与发达国家在注册数量上有较大差距且存在着非常大的地区不均衡性，中国临床试验注册从观念建立至注册自觉性是一个渐进的过程，以此促进高质量临床试验。

Abstract:

Objective To observe the global and Chinese children clinical trial registration. Methods By Using advanced search of ClinicalTrials.gov database, some search rules were limited and the number of children aged from 0 to 17 clinical trial registration was collected. We ascertained the countries to obtain the number of children clinical trial registration. According to the different groups as sub-population, recruitment and study type, registration number was further stratified for analysis.Results There were 43 349 studies had been registered in the ClinicalTrials.gov until December 31, 2015, America, Europe, Asia, Australia, Africa accounts for 53.8%, 21.27%, 14.5%, 2.30%, 4.2% from total, respectively. The top 5 countries in registration numbers were United States, Canada, China, France and United Kingdom, Mainland China ranked 9th in countries list. It was found that registration number was highly correlated with the GDP (dollars) of country (correlation = 0.92), this indicator in children series was equal to 0.62. The ratio of the number of Preparing, Recruiting, Activated and Completion projects in United States was 1∶12∶5.5∶26.5, however, this ratio was 1∶8.6∶1.6∶8.0 in China. The number of observational study was one third of interventional's. Top 5 provinces in Mainland China were Beijing, Shanghai, Guangdong, Jiangsu and Zhejiang, they accounted for 95.4%（1 151/1 207） of children clinical trial registration in Mainland China.Conclusion From the point of registration number, there is still a huge gap among China and Euro-American developed countries. Moreover, regional difference in China is very serious. Although change of concept for clinical trial registration from establishment to automatic registration is a slow and gradual process, but it can improve the quality of children clinical trial for China.