Situation analysis for drug clinical trial institutions.
- Author:
Yin-Ying CHEN
;
Ping WU
;
Jie WANG
- Publication Type:Journal Article
- MeSH:
China;
Clinical Trials as Topic;
standards;
Drug Evaluation;
Drug Therapy;
standards;
trends;
Drugs, Chinese Herbal;
standards;
therapeutic use;
Humans;
Quality Control;
Research
- From:
China Journal of Chinese Materia Medica
2014;39(16):3208-3210
- CountryChina
- Language:Chinese
-
Abstract:
Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.
