我国儿童注册临床试验现状分析

目的：检索并调查中国临床试验注册中心的儿童临床试验现状。方法：计算机检索中国临床试验注册中心中以儿童为研究对象的临床试验,检索时间截止2014年4月。两名研究者独立筛选检索到的临床试验,并按预先设计的资料提取表提取疾病类型、资助基金和注册时间等内容,并将数据输入Excel,使用SPSS17.0软件进行统计分析。结果：检索获得儿童临床试验133项,儿童临床试验注册数量随着时间推移而不断增加;申请人所在单位为医院的为72项（54.1%）。93（69.9%）项的注册号状态是预注册,85.7%的试验获得伦理委员会的批准,政府经费资助的试验项目最多,占29.6%;干预措施类型中,药物干预最多（62,46.6 %）,干预性研究有78项（58.6 %）,随机平行对照试验占64.7%,仅24.8%的试验说明使用了盲法。试验资料收集、分析、管理单位为医院的试验项目数分别为47（35.1%）,45（33.8%）,33（24.6%）。结论：儿童临床数量在不断增加,且大部分儿童临床试验受政府资助,这将有助于减少部分偏倚,今后研究应该更多的关注注册的临床试验的注册质量问题,推动儿童临床试验的发展。

The current situation of clinical trials in children in China

Objective: To identify clinical trials in children and survey of their characteristics in Chinese Clinical Trial Registry(ChiCRT).Methods:All records within the ChiCRT were scanned for clinical trials in children. Two reviewers screened the retrieved records for potentially relevant papers and extracted details on type of disease, clinical study categories and fund, and registration year.Results:133 were included,the frequency of clinical trials in children were found to increase over time The number of clinical trials in children in China is increasing, applicant"s institution of 72(54.1%)clinical trials were hospital, registration status of 93(69.9%)clinical trials were prospective registration, 85.7% clinical trials were approved by ethic committee,29.6% clinical trials were supported by public fund,62(46.6%)clinical trials focused on the drug, study type of 78(58.6 %)clinical trials were interventional study, 64.7% clinical trials were randomized controlled trials,only 24.8% clinical trials used blinding. data collection institution of 47(35.1%)clinical trials were hospital, data analysis institution of 45(33.8%)clinical trials were hospital,data management institution of 33(24.6%)clinical trials were hospital..Conclusions:This investigation shows the number of clinical trials was increased, majority of clinical trials were supported by public organization, which may be reduce the other bias. Therefore, we suggest that future research on assessment of registration quality of trials in children.