title: [Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].
abstract: Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.
authors.affiliation: Institute of Basic Research in Clinical Basis Medicine, China Academy of Chinese Medical Science, Beijing 100700, China. zhinanb2010@yahoo.com.cn
authors.forename: Yanming
authors.initials: Y
authors.lastname: Xie
authors.forename: Xu
authors.initials: X
authors.lastname: Wei
mesh_terms: D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D012107:Research Design
chemical_list: D004365:Drugs, Chinese Herbal