加强临床数据管理对药品审评的重要作用  

The importance of clinical data management in improvement of drug evaluation

作　　者：黄钦[1] 王骏[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《药学学报》2015年第11期1408-1409,共2页Acta Pharmaceutica Sinica

摘　　要：国内虽然对于临床研发和临床数据质量的认识一直在不断提高,但从现状来看,仍然存在研究团队的数据管理水平不高等问题。而互联网和信息技术的发展以及药物创新作为国家战略对我国临床试验数据进行规范管理的要求已非常迫切必要。药品审评中良好的临床数据质量是首要基础,近年来药审中心开展了多方面工作着力加强国内临床试验中的数据管理工作,本文对此进行了介绍和阐述。Although the importance of clinical data is drawing more attention in drug development inChina, the clinical data management is not good enough in the clinical trials right now. With the developmentof internet and progress of information technology, especially with the setup of the state innovation strategy fordrug development, it is necessary and urgent to improve the clinical data quality. Good data quality is theprimary basis of technical evaluation of drug at the marketing authorization. So Center for Drug Evaluation ofCFDA has made some endeavors to enhance data management in the clinical trials in recent years. This articleis focused on these aspects of data managment.

关 键 词：药品审评 临床试验 数据管理 

分 类 号：R969[医药卫生—药理学]