Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials.
- Author:
Yanming XIE
1
;
Yanping WANG
;
Feng TIAN
;
Yongyan WANG
Author Information
1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. zhinanb2010@yahoo.com.cn
- Publication Type:Journal Article
- MeSH:
Clinical Trials, Phase IV as Topic;
Humans;
Medicine, Chinese Traditional;
adverse effects;
Product Surveillance, Postmarketing;
Research Design
- From:
China Journal of Chinese Materia Medica
2011;36(20):2764-2767
- CountryChina
- Language:Chinese
-
Abstract:
As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.
