中国临床试验注册中心在册药物临床试验分析

目的:了解中国临床试验注册中心(ChiCTR)在册的药物临床试验的现状和特点。方法:检索ChiCTR数据库(截至2011年11月9日),记录相应药物临床试验并从目标疾病、地域分布、经费来源、研究类型、研究设计等方面进行分析。结果与结论:在ChiCTR注册的药物临床试验共714项,以治疗恶性肿瘤(27.9%)、循环系统疾病(13.0%)等的研究为主;经费主要来源于研究者及所在单位、制药企业和国家财政3个方面;多为单中心、治疗性试验;研究地点集中在北京市、上海市、广东省和四川省等地;Ⅳ期临床试验411项(57.6%),Ⅰ、Ⅱ、Ⅲ期及临床预试验比例都在10%左右;明确应用盲法的随机对照试验占45.1%。

Analysis of Clinical Trials of Drugs Registered in ChiCTR

OBJECTIVE： To investigate the current status and characters of clinical trials registered in Chinese clinical trial reg- istry （ChiCTR）. METHODS： Retrieved from ChiCTR database （up to Nov. 9th, 2011）, clinical trials of relevant drugs were re- corded and analyzed in terms of target diseases, geographical distribution, study type, study design and sponsors. RESULTS ＆ CONCLUSIONS： Totally 714 clinical trials have been registered in ChiCTR, mainly including malignant tumor study （27.9%） and circulation system disease study （13.0%）, which are mainly funded by researchers and its institution, manufactories and national fi- nance. Most of trials are single center therapeutic trials, and major trials are conducted in developed areas such as Beijing, Shang- hai, Guangdong province and Sichuan province; there are 411 clinical trials at phase Ⅳ （57.6%）, and clinical trials at phaseⅠ , Ⅱ and Ⅲand clinical preliminary trials all occupy about 10% ; randomized controlled trials which adopt blind method take up 45.1%.