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目的:分析我国(不含香港、台湾地区)开展国际多中心药物临床试验的现状。方法:通过2016年1月1日以前在Clinical Trials.gov登记注册的临床试验进行检索、筛选,对2005年1月1日至2016年1月1日在我国大陆开展的国际多中心药物临床试验数据进行统计,分析其治疗领域、开展时间、样本量、研究类型、研究设计、申办方等。结果:该网站上注册的我国开展的国际多中心药物临床试验共652项,大多由诺华公司、拜耳公司、罗氏公司、阿斯利康公司、辉瑞公司等外国制药企业申办,主要治疗领域为肿瘤、循环系统疾病和内分泌、营养和代谢疾病等。其中,有464项(约71%)为Ⅲ期临床试验,其次为Ⅱ期和Ⅳ期临床试验。预期样本量普遍较大,多为300~9 999例共430项,约占66%。研究类型主要为干预性研究共621项约占95%,干预性研究又以双盲试验为主,共375项。结论:在我国开展的国际多中心药物临床试验项目多为外国制药企业开展,且试验分期多集中在Ⅲ期临床试验。因此,一方面,我国制药企业仍需继续加强研发能力和整体水平以增强竞争力,进而积极参与到国际多中心药物临床试验项目中。另一方面,我国仍需通过完善国际多中心临床试验相关法律政策来真正实现与国际接轨。
Objective: To analyze the status quo of international multi-center drug clinical trial in China (excluding Hong Kong and Taiwan). METHODS: We searched and screened clinical trials registered with Clinical Trials.gov before January 1, 2016, and conducted an international multicenter clinical trial on our mainland from January 1, 2005 to January 1, 2016 Data statistics, analysis of its treatment areas, to carry out the time, sample size, type of research, research design, sponsor and so on. Results: A total of 652 international multicentre clinical trials were conducted in China. Most of them are bid by foreign pharmaceutical companies such as Novartis, Bayer, Roche, AstraZeneca, Pfizer, etc. The main therapeutic areas are cancer, Circulatory system diseases and endocrine, nutrition and metabolic diseases. Of these, 464 (about 71%) were phase III clinical trials, followed by phase II and IV clinical trials. Expected sample size is generally larger, mostly more than 300 ~ 9999 a total of 430, accounting for 66%. The main types of research intervention for a total of 621 about 95%, interventional studies and double-blind trial again, a total of 375 items. Conclusion: Most of the international multicentre drug clinical trials carried out in our country are carried out by foreign pharmaceutical companies, and the test staging is mostly concentrated in phase Ⅲ clinical trials. Therefore, on the one hand, China’s pharmaceutical companies still need to continue to strengthen their R & D capabilities and overall level in order to enhance their competitiveness so as to actively participate in the international multi-center drug clinical trial projects. On the other hand, our country still needs to truly achieve international standards through the improvement of relevant legal policies of international multicenter clinical trials.