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

发布时间：2018-05-05 05:41

本文选题：制药企业 + 抗糖尿病药物　；参考：《中国新药杂志》2017年17期

【摘要】：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。
[Abstract]:Objective: to analyze the current situation of clinical trials of antidiabetic drugs carried out by foreign pharmaceutical enterprises in mainland China, and to provide reference for improving the management of clinical trials in China. Methods: to search the Clinical Trials.Gov database from January 1, 2007 to December 1, 2016, and to screen out the clinical trials of antidiabetic drugs with foreign pharmaceutical enterprises as the sponsors / collaborators in mainland China. Statistical analysis of the trial stages, sample size, design and research types, experimental drugs, sponsors and so on. Results: 108 clinical trials of anti-diabetic drugs were conducted by foreign pharmaceutical enterprises in China. Of these, 2 were jointly carried out at home and abroad, 106 were carried out by foreign pharmaceutical enterprises alone, 52 were carried out in China alone, and 56 were carried out by international multi-center experiments. A total of 52 clinical trials were carried out in the third stage. The main type of study was interventional study, with 102 items. Major European and American pharmaceutical companies such as Novo Nord, Sanofie, AstraZeneca, Brigham Ingham, Lilly, Novartis and other large pharmaceutical companies account for the majority of clinical trial resources. Conclusion: the level of clinical trials of antidiabetic drugs in China has been gradually recognized internationally. It is necessary to further strengthen the construction of medical institutions and improve the policy environment in order to participate in more international clinical trials of antidiabetic drugs.
【作者单位】：沈阳药科大学工商管理学院;
【基金】：国家“重大新药创制”科技重大专项资助项目(2013ZX09301305)
【分类号】：R95

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