The importance of clinical data management in improvement of drug evaluation.
- Author:
Qin HUANG
;
Jun WANG
- Publication Type:Journal Article
- From:
Acta Pharmaceutica Sinica
2015;50(11):1408-9
- CountryChina
- Language:Chinese
-
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.
