国内外儿科药物临床试验发展现状

doi:10.3969/j.issn.1000-3606.2020.08.019

临床儿科杂志 ›› 2020, Vol. 38 ›› Issue (8): 636-.doi: 10.3969/j.issn.1000-3606.2020.08.019

国内外儿科药物临床试验发展现状

汪君铱 1,　沈佳佳 2,　李春梅 2,　漆林艳 2,　倪韶青 2

1.杭州医学院（浙江杭州　310053）；2 .浙江大学医学院附属儿童医院临床试验机构办公室　国家儿童健康与疾病临床医学研究中心（浙江杭州　310052）

出版日期:2020-08-15 发布日期:2020-08-11
通讯作者: 倪韶青　电子邮箱：chnsq@zju.edu.cn
基金资助:
国家自然科学基金项目(No.81573516)；浙江省基础公益研究计划项目（No.LGF19H310004）；国家科技部“重大新药创制” 科技重大专项基金（No.2017ZX09304029）

Development of pediatric clinical trials at home and abroad

　WANG Junyi1, SHEN Jiajia2, LI Chunmei2, QI Linyan2, NI Shaoqing2

1. Hangzhou Medical College, Hangzhou 310053, Zhejiang, China); 2 Clinical Trial Institution Office, The Children’s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou 310052, Zhejiang, China

Published:2020-08-15 Online:2020-08-11

摘要/Abstract

摘要： 儿童不是缩小版的成人，从新生儿到青春期整个过程中，组织器官和功能发生有很大的变化。儿科药物研发和临床试验是儿童用药安全的重要保障，但儿科药物研发和临床试验开展困难亦是全球性的问题。本文综述欧美及国内儿科药物临床试验的政策法规、临床试验现状，以期为我国儿科药物研发和临床试验开展提供参考。

关键词: 药物研发；　临床试验；　政策法规；　儿科

Abstract: 　Children are not smaller-sized adults, their tissues, organs and functions change dramatically from newborn to adolescence. Pediatric drug development and clinical trials are important safeguards for children's drug safety. However, pharmaceutical research and clinical trials are difficult to perform in children, which is a universal problem in the world. This article reviews the policies, regulations, and clinical trials of pediatric drugs in Europe, America, and China, which intends to provide references for the future development of pediatric drug clinical trials in China.

Key words: drug development;　clinical trials;　policies and regulations; pediatrics

汪君铱，沈佳佳，李春梅，等. 国内外儿科药物临床试验发展现状[J]. 临床儿科杂志, 2020, 38(8): 636-.

WANG Junyi, SHEN Jiajia, LI Chunmei, et al. Development of pediatric clinical trials at home and abroad[J]. Journal of Clinical Pediatrics, 2020, 38(8): 636-.

国内外儿科药物临床试验发展现状

Development of pediatric clinical trials at home and abroad

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