Design and Analysis of Post-marketing Research

• Published in: Chinese journal of integrative medicine Vol. 19; no. 7; pp. 488 - 493
• Main Author: 周晓华 杨伟
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.07.2013
• Subjects: Anaphylaxis - chemically induced; Drug-Related Side Effects and Adverse Reactions; Drugs, Chinese Herbal - adverse effects; Feature Article; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; Medicine; Medicine & Public Health; Neural Networks (Computer); Product Surveillance, Postmarketing; Research Design; Rhabdomyolysis - chemically induced; 上市; 中国医药; 医药产品; 因果关系; 安全性; 挑战性; 组成部分; 观测设计; safety surveillance; pharmacovigilance methods; traditional Chinese medicine post-marketing research; propensity score
• ISSN: 1672-0415; 1993-0402; 1993-0402
• DOI: 10.1007/s11655-013-1501-z

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.