Page 13 - 2020年17期

注册于中国临床试验注册中心的儿科药物临床试验项目特征分

析 Δ

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张冠东 ，杨 钰，赵瑞玲（山西省儿童医院药物临床试验机构办公室，太原 030013）
＊
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2020）17-2055-06
DOI 10.6039/j.issn.1001-0408.2020.17.02

摘 要 目的：为规范我国儿科药物临床试验项目开展、促进儿科人群用药的开发与应用提供参考。方法：检索中国临床试验注
册中心（Chi CTR）数据库，收集所有研究对象年龄＜18周岁的药物临床试验项目，检索时限从建库起至2019年10月1日，对其项
目名称、研究所涉疾病/系统、研究所处阶段、注册时间、注册状态、研究负责单位地域分布、经费来源、研究类型、是否设置数据管
理委员会、征募研究对象情况、伦理委员会批准情况、是否采用盲法、是否采集人体标本及人体标本去向等信息进行统计分析。结
果：共收集到儿科药物临床试验231项，共涉及21个类别的系统/疾病，包括肿瘤及瘤样病变、眼科疾病、变态反应性疾病等；研究
所处阶段以上市后药物临床试验的项目有85项（占36.80％），Ⅰ～Ⅳ期药物临床试验共有77项（占33.33％）；注册项目数量逐年
增加，有179项（77.49％）为预注册，52项（22.51％）为补注册；注册项目较多的前5位地区分别为北京、上海、广东、重庆、浙江，其
项目数共占纳入项目总数的66.23％（153/231）；经费来源主要为自筹（57.85％）、医院资助（20.18％）、地方财政资金（10.31％）；研
究类型主要为干预性研究和观察性研究，共占 88.31％；有 145 项（占 62.77％）研究暂未确定是否设置数据管理委员会；有 201 项
（占87.01％）研究通过了相关机构的伦理委员会审查；有168项（占72.73％）研究未明确是否采用盲法；有133项（占57.58％）研究
采集了人体标本，采集的人体标本去向主要为使用后销毁。结论：注册于Chi CTR的儿科药物临床试验注册数量呈逐年递增趋
势，但存在地域不均衡性；我国研究者的药物临床试验注册观念正逐步建立，且已意识到数据管理对研究质量的重要性，对采集的
试验标本的管理也较为规范。建议相关部门加大对临床试验注册的宣传，完善临床试验注册管理制度；相关研究者应提高临床试
验注册意识，规范进行注册申报和试验项目管理。
关键词 中国临床试验注册中心；儿科人群；药物临床试验；特征

Characteristics Analysis of Pediatric Drug Clinical Trials Registered in Chinese Clinical Trial Registry
ZHANG Guandong，YANG Yu，ZHAO Ruiling（Office of Drug Clinical Trial Institution，Shanxi Children’s
Hospital，Taiyuan 030013，China）

ABSTRACT OBJECTIVE：To provide reference for standardizing pediatric clinical trials and promoting the development and
application of pediatric medication in China. METHODS：Chinese Clinical Trial Registry（Chi CTR）database were searched to
collect all clinical trials related to pediatric population under 18 years old from the inception to Oct. 1st，2019. Those clinical trials
were analyzed statistically in respect of name of registered project，involved disease/system，research stage，registration time，
registration status，regional distribution of research institutions，source of funds，research type，whether data management
committee was set up，situation of recruited research objects，ethics committee approval status，whether blind method was adopted，
whether to collect human specimens and whereabouts of human specimens. RESULTS：A total of 231 pediatric drug clinical trials
were included. The clinical trials involved 21 kinds of diseases/systems，mainly were tumors and tumor-like lesions，ophthalmic
diseases and allergic disease. The research stage has the most items（85 trials，36.80％）in post-marketing drug clinical trials；there
were 77 items of phase Ⅰ-Ⅳ clinical trials（33.33％）. The number of pediatric drug clinical trials was increased year by year，and
among which 179 trials were pre-registered（77.49％），52 trials were supplementary registration（22.51％）. Beijing，Shanghai，
Guangdong，Chongqing and Zhejiang were the major regions where pediatric drug clinical trials were carried out，and the clinical
trial projects of which accounted for 66.23％（153/231）of the total number of included projects. The funding sources were mainly
self-financing（57.85％），hospital finance（20.18％），and local government finance（10.31％）. The main type of research was
intervention study and observational study，accounting for 88.31％ in total. Totally 145 trials（62.77％）had not yet determined
whether to set up a data management committee；201 trials（87.01％）had passed the review of the ethics committee of the relevant
institution；168 trials （72.73％） did not clarify whether the
Δ 基金项目：国家科技重大专项项目（No.2017ZX09304029-
blind method was used；133 trials （57.58％） had collected
001-001）
human specimens，and the collected human specimens were
＊主管药师，硕士。研究方向：临床试验质量管理。电话：0351-
3360875。E-mail：794446155@qq.com mainly destroyed after use. CONCLUSIONS：The number of
# 通信作者：主任药师。研究方向：药事管理、临床药理。电话： pediatric drug clinical trials registered in Chi CTR is
0351-3361378。E-mail：ruiling.zhao@163.com increasing but there is regional imbalance. Researchers have

中国药房 2020年第31卷第17期 China Pharmacy 2020 Vol. 31 No. 17 ·2055 ·