Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials
Xie, Y.; Wang, Y.; Tian, F.; Wang, Y.
Zhongguo Zhong Yao Za Zhi 36(20): 2764-2767
2011
ISSN/ISBN: 1001-5302 PMID: 22292359 Document Number: 650353
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.