外国制药企业在我国开展抗糖尿病药物临床试验的现状分析

Analysis of the situation of clinical trials for antidiabetes drugs supported by foreign pharmaceutical industries in China

目的:分析外国制药企业在我国大陆开展抗糖尿病药物临床试验的现状,为完善我国临床试验管理提供参考。方法:在Clinical Trials.Gov数据库进行检索,时间段为2007年1月1日至2016年12月1日,筛选出在中国大陆进行的申办方/合作者为外国制药企业的抗糖尿病药物临床试验,进行数据统计分析其试验分期、样本量、设计与研究类型、试验药物、申办方等。结果:外国制药企业在我国开展的抗糖尿病药物临床试验共108项。其中,国内外合作开展的2项,外国制药企业单独开展的106项;在我国单独开展的52项,国际多中心试验56项。总体以Ⅲ期临床试验为主,共52项(47%)。研究类型以干预性研究为主,共102项(94%)。申办方如诺和诺德、赛诺菲、阿斯利康、勃林格殷格翰、礼来、诺华等欧美大型制药企业占据了大多数临床试验资源。结论:我国的抗糖尿病药物临床试验水平已逐渐得到国际认可,我国需进一步加强医疗机构建设和改善政策环境,争取参与更多的国际抗糖尿病药物临床试验。

Objective： To analyze the situation of clinical trials for antidiabetes drugs supported by foreignpharmaceutical industries in China（ except Hongkong and Taiwan Region）,which can provide references for improving the level of clinical trials. Methods： The clinical trials for antidiabetes drugs supported by foreign pharmaceutical industries in China（ registered on the Clinical Trials. gov from Jan 1,2007 to Dec 1,2016） were searched. These trials were analyzed from study phase,sample size,study design,drugs,sponsors and so on.Results： The number of the clinical trials for antidiabetes drugs supported by pharmaceutical industries in China was 108 during the time. among the trials,there were 2 supported by domestic and international cooperation,and 106 supported by foreign pharmaceutical industries alone. There were 52 clinical trials conducted only in China,and 56 multinational clinical trials. In total,52（ 47%） were in phase Ⅲ,102（ 94%） were interventional studies.The most clinical trials are supported by pharmaceutical companies such as Novo Nordisk,Sanofi,Astrazeneca,Boehringer Ingelheim,Eli Lilly,and Novartis. Conclusion： The level of the clinical trials of antidiabetes drugs in China have gradually been recognized internationally. To participate in more international clinical trials of antidiabetes drugs,we need to further strengthen the construction of medical institutions and improve the policy environment.