title: [Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].
abstract: In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. fyk0317@126.com
authors.forename: Yingkun
authors.initials: Y
authors.lastname: Fu
authors.forename: Yanming
authors.initials: Y
authors.lastname: Xie
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D018401:Sample Size