外国制药企业在中国开展临床试验现况分析——基于Clinical Trials.gov网站登记数据的统计分析

Analysis of clinical trials supported by foreign pharmaceutical industries in China

目的:本文通过查阅ClinicalTrials.gov网站数据库登记的有关内容,对在中国开展的临床试验进行了归纳总结和分析。方法:"ClinicalTrials.gov"是全球最大的临床试验登记网站,提供由企业或政府申办的最新的有关临床试验的情报。通过查阅2007年5月8日前所登记注册临床试验的检索结果,对外国制药企业在中国进行的独立开展或参与国际多中心临床试验登记数据进行了统计分析。结果:在中国,由制药企业赞助的临床试验有97件,其中58件是国际多中心试验,39件是中国单独进行的试验。主要的研究对象疾病为肿瘤、循环系统疾病、中枢系统疾病及感染。在中国单独试验中,临床试验受试药均为在海外上市的药,这些试验的目的是为了在中国扩大适应症或是为了进口中国。而在国际多中心试验中的受试药有在海外处于IV期,还有处于III期,这些试验的目的是为了取得中国人的试验数据或是为了促销而进行的。在中国单独试验中有一半,在国际多中心试验中有67%是随机双盲试验。中国临床试验的特点是参加医院数集中在10个左右。结论:外国制药企业让中国参与更多的国际多中心临床试验,加快新药研发进程。

Objective：To summarize and analyze the status of clinical trials in China using the data from ＂ClinicalTrials.gov＂ database.Methods： ＂ClinicalTrials.gov＂ provides regularly up-to-date information on federally and privately supported clinical research in human volunteers.It is the biggest clinical trial registry database all over the world.The worldwide information on clinical trials（including all data about China） was collected from ＂ClinicalTrials.gov＂.Results： The number of clinical trials,which were supported by industry by now,was 97 in China.Among the trials,there were 58 multinational clinical trials,and 39 clinical trials conducted only in China.The most popular diseases were cancer,circulation system disorders,central nervous system disorders and infection diseases.All of the drugs used for clinical trials conducted only in China were already marketed in a foreign country,so all the clinical trials were conducted either for seeking new indications or for import.On the other hand,drugs used for multinational clinical trials were those developed in phase 3 or in phase 4 in a foreign country;the aims were to gain Chinese data or to promote marketing.Half of the trials conducted only in China and 67% trials conducted multinationally were double blind,randomized trials.Most of the clinical trials in China,either the ones conducted only in China or multinational ones,were conducted in about 10 units.Conclusion： The foreign pharmaceutical industries let Chinese take part in a lot of clinical trials in order to develop a new medicine rapidly.