2016-2020年中国银屑病临床试验质量评估

Quality assessment of clinical trials in psoriasis,2016-2020

目的:评估2016-2020年国内外企业发起的临床试验的质量,为中国银屑病临床研究标准化构建提供参考。方法:从全球临床试验注册数据库、国家食品药品监督管理总局药品审评中心药物临床试验登记与信息公示平台、中国临床试验注册中心三个临床试验登记平台中提取2016年1月至2020年12月注册登记的银屑病治疗药物临床试验,对试验的规范性、方法学设计、研究终点指标进行分析。结果:2016-2020年国内外分别有123和314个临床试验信息,国内研究采用随机分配比例高于国外(91.9%比77.4%),而国内有49.6%试验<100人,这个比例稍高于国外(43.9%)。试验设计方面,国内外均常选择平行对照方法;国外有32.2%试验采取四盲设计,国内44.7%临床试验是双盲法。国外和国内各有28.0%和19.5%试验选择银屑病皮损面积及严重程度指数(PASI)做研究终点评价指标。结论:我国临床试验的质量已有很大程度提高,但和国际先进水平相比仍存在一定差距,应注重中国临床试验的设计与实施,提高中国临床试验的总体质量。

Objective:To evaluate the quality of clinical trials in domestic and foreign enterprises during 2016-2020,and to provide reference for the standardization construction of clinical research on psoriasis in China.Methods:The drug clinical trials of psoriasis treatment were researched from Clinicaltrial.gov,Registration and Information Disclosure Platorm of Cencer for Drug Evaluation of China Food and Drug Administration and Chinese Clinical Trial Registry from January 1,2016 to December 31,2020.The standardization,methodological design and endpoint index of the study were analyzed.Results:A total of 123 and 314 clinical trials at home and abroad were collected.The rate of random allocation in domestic studies was 91.9%,which was higher than that in foreign studies(77.4%).Howerver,the rate of cases fewer than 100 in domestic studies was 49.6%,which was higher than foreign studies(43.9%).Parallel control was the most common method at home and abroad.In foreign countries,32.2%of clinical trials were the four-blind design,and 44.7%of domestic clinical trials were double-blind.PASI as evaluation methods to access the efficacy in 19.5%of domestic studies and 28.0%of foreign studies.Conclusion:The quality of clinical trials in China has been greatly improved,but there is still a gap compared with the international advanced level.Attention should be paid to the design and implementation of clinical trials in China to improve the overall quality of clinical trials in China.