title: Utilization of health care databases for pharmacoepidemiology.
abstract: Pharmacoepidemiology is the study of the utilization and effects of drugs in clinical and population settings, and the outcomes of drug therapy. The growing trend of recording computerized data that will increasingly be automated into health care delivery is making the use of large datasets more and more common in pharmacoepidemiologic research. Most retrospective databases offer large populations and longer observation periods with real-world practice and can answer a variety of research questions quickly and cost-effectively. Observational studies, specifically using large databases, can complement findings from randomized clinical trials (RCTs) by assessing treatment effectiveness in patients encountered in daily clinical practice, although they are more exposed to bias and certainly are lower on the hierarchy of evidence than RCTs. Furthermore, careful defining of the research question with appropriate design and application of advanced statistical techniques, e.g., propensity-score analysis or marginal structural models, can yield findings with validity and improve causal inference of treatment effects. Some existing guidelines for comparative effectiveness help decision makers to evaluate the quality of observational studies comparing the effectiveness of various medical products and services. Thus, the trend for utilization of databases for pharmacoepidemiology will continue to grow in coming years.
authors.affiliation: Division of Genomic Epidemiology and Clinical Trials, Advanced Medical Research Center, Nihon University School of Medicine, 30-1 Oyaguchi-Kamimachi, Itabashi-ku, Tokyo 173-8610, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Yayoi
authors.initials: Y
authors.lastname: Nishida
authors.forename: Satoshi
authors.initials: S
authors.lastname: Asai
mesh_terms: D016208:Databases, Factual; D003695:Delivery of Health Care / Q000706:statistics & numerical data; D006801:Humans; D017891:Pharmacoepidemiology / Q000379:methods*; D012107:Research Design; D016896:Treatment Outcome