摘要
目的:研究我国儿科药物临床试验登记现状,为促进儿科药品研发提供建议与参考。方法:收集国家药品监督管理局药品审评中心(CDE)药物临床试验登记与信息公示平台中儿科药物公示信息,对试验类型、试验分期、受试者招募、保险、临床试验数据监察委员会(DMC)等信息采用比率法进行统计分析。结果与结论:截至2020年6月份,平台共登记10 933项临床试验;儿科专用药物临床试验为139项;儿科药物临床试验中Ⅲ期临床登记数量居多;按照药物类型统计,生物制品登记数量最多,其次是化学药品,中药登记数量最少。此外,我国企业儿科药品研发积极性不高,儿科药物临床试验存在周期长、受试者招募困难等问题。
Objective: To analyze the current status of pediatric drug clinical trials in China so as to provide reference for its improvement. Methods: Information about pediatric drug clinical trials was collected from the clinical trials explicitly labeled of CDE. The clinical trial type,clinical trial stage,recruitment,insurance and DMC were analyzed statistically by ratio analysis method. Results and Conclusion: By June 2020,10 933 clinical trials had been registered on the platform,including 139 pediatric drugs. Among these pediatric drug clinical trials,phase Ⅲclinical trials had the largest number. In aspect of drug classes,biological products had the largest number of clinical trials,followed by chemical drugs,while traditional Chinese medicine had the least registration number. In addition,the enthusiasm of children’s drug companies in China for new drug research and development is not high. There are some problems in pediatric drug clinical trials,such as the long trial period and difficult recruitment of subjects.
作者
苏娜
田丽娟
SU Na;TIAN Li-juan(Shenyang Pharmaceutical Universily,Shenyang 110016,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2021年第2期150-153,共4页
Chinese Journal of New Drugs
关键词
儿科药物
临床试验
数据分析
pediatric drug
clinical trials
data analysis
