黄钦, 王骏. 加强临床数据管理对药品审评的重要作用J. 药学学报, 2015,50(11): 1408-1409.
引用本文: 黄钦, 王骏. 加强临床数据管理对药品审评的重要作用J. 药学学报, 2015,50(11): 1408-1409.
HUANG Qin, WANG Jun. The importance of clinical data management in improvement of drug evaluationJ. Acta Pharmaceutica Sinica, 2015,50(11): 1408-1409.
Citation: HUANG Qin, WANG Jun. The importance of clinical data management in improvement of drug evaluationJ. Acta Pharmaceutica Sinica, 2015,50(11): 1408-1409.

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

  • 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。

     

    Abstract: Although the importance of clinical data is drawing more attention in drug development in China, the clinical data management is not good enough in the clinical trials right now. With the development of internet and progress of information technology, especially with the setup of the state innovation strategy for drug development, it is necessary and urgent to improve the clinical data quality. Good data quality is the primary basis of technical evaluation of drug at the marketing authorization. So Center for Drug Evaluation of CFDA has made some endeavors to enhance data management in the clinical trials in recent years. This article is focused on these aspects of data managment.

     

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