儿科人群药物临床试验技术指导原则(征求意见稿)解读(二)  

Interpretation of guidance for clinical investigation of medicinal products in the pediatric population

作　　者：张弨[1] 王晓玲[2] 母双[3] 翟所迪[1] 李在玲[4] 单爱莲[5] 

机构地区：[1]北京大学第三医院药剂科,北京100191 [2]北京儿童医院临床药理机构,北京100231 [3]北京大学人民医院医学伦理委员会,北京100044 [4]北京大学第三医院儿科,北京100191 [5]北京大学第一医院临床药理研究所,北京100191

出　　处：《中国临床药理学杂志》2015年第24期2499-2501,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：儿童作为特殊人群,疾病种类和临床用药与成年人群有很大区别。儿童药物临床试验的开展为儿童新药研发和临床用药提供可靠临床数据,有利于儿童身体健康。但由于儿童的特殊性,开展儿童药物临床研究有其特殊考虑,尤其是临床试验方案的设计更加具有难度和挑战性。2015年,国家食品药品监督管理总局出台了《儿科人群药物临床试验技术指导原则(征求意见稿)》,这使得我国儿科人群药物临床试验更加规范,临床试验更加科学和伦理。本文对该指导原则进行部分解读,从而有助于儿科人群药物临床试验的规范开展。The pediatric population is different from adults in their disease types and medication use in clinics.The drug clinic trial in pediatric population provides reliable clinic data for new drug development and medication use,and is helpful to promote the health of children.However,considering the specificity of children,it is changeable to conduct the drug clinic trials,especially for the study protocol design.Accordingly,CFDA issues the guidance for clinical investigation of medicinal products in the pediatric population,which ensure the clinical trials are more scientific and ethic.This paper means to interpret the guidance and therefore to help the development of clinical trials in pediatric population.

关 键 词：儿科人群 儿童 药物临床试验 解读 

分 类 号：R985[医药卫生—药品] R246.4[医药卫生—药学]