中国临床研究注册与发表情况:8年后再次调查

Re-investigation after 8 years on the publication of Chinese clinical trials after registration

目的 调查中国临床研究注册后其结果在注册中心和期刊的发表情况.方法 人工检索美国临床研究注册网站(www.clinicaltrials.gov)2009年7月24日前注册的中国临床研究,计算机检索中国知网(CNKI)、万方数据库、维普数据库、PubMed、EMbase数据库,检索时间为建库至2017年12月31日.筛选中国临床研究,调查其结果在注册中心和期刊的发表情况.结果 共纳入654个中国临床研究,仅3.8%(25/654)在Clinicaltrials.gov发表了研究结果,11.3%(74/654)的临床研究的文献目录含有属于该临床研究的结果发表文献(有效文献).临床研究从注册至完成时间和研究完成至结果发表时间主要间隔集中在2年和3年.结论 我国注册的临床研究结果发表比例及质量较低,反映了研究人员对研究结果发布规则的不了解或不重视.

Objective To investigate the publication status and quality in registration centers and journals of Chinese clinical trials after registration.Methods The Chinese clinical trials registered on the US Clinical Trial Registration website(www.clinicaltrials.gov)before July 24,2009 were searched.China Knowledge Network(CNKI),Wanfang Database,VIP Database,PubMed,and EMbase Database were searched by computer from inception to December 31,2017,to investigate the outcome publication of these clinical trials in the registration center and journals.Results A total number of 654 clinical trials were included in this study.Only 25 clinical trials,accounted for 3.8%,published trial outcome on the US Clinical Trials Register,74 clinical trials,accounted for 11.3%,were published in the journals(effective literature).Most of the trials took 2 to 3 and in both from registration to completion and study closure to outcome publication.Conclusions The proportion and quality of clinical trial outcome publication in China were low,which alerting us that researcher should pay more attention to the trial outcome publication.