Design and Analysis of Post-marketing Research

作     者：周晓华 杨伟 

作者机构：Department of BiostatisticsSchool of Public HealthUniversity of Washington School of StatisticsRenmin University of China Biostatistics UnitVA Seattle Medical Center Institute of Basic Research in Clinical MedicineChina Academy of Chinese Medical Sciences 

基　　金：Supported by the Research on Key Techniques of Reevaluation of Post-marketing Chinese Medicine,the Ministry of Science and Technology(No.2009ZX09502-030) the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(Grant No.Z0215) the Seventh-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(Grant No.Z0255) 

出 版 物：《Chinese Journal of Integrative Medicine》 (中国结合医学杂志（英文版）)

年 卷 期：2013年第19卷第7期

页      码：488-493页

摘      要：A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine （TCM） products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

主 题 词：traditional Chinese medicine post-marketing research safetysurveillance pharmacovigilance methods propensity score 

学科分类：1007[医学-药学类] 02[经济学] 0202[经济学-财政学类] 020201[020201] 10[医学] 

核心收录：

D　O　I：10.1007/s11655-013-1501-z

馆 藏 号：203161106...