Pharmacoepidemiology

The course is intended to provide students with an understanding of the objectives, methods and applications of pharmacoepidemiology -- the study of the use and effects of drugs in diverse populations. Students will be exposed to the role of Pharmacoepidemiology in the biopharmaceutical development process, from the perspective of regulators (e.g. FDA), policymakers (e.g. Health Technology Assessment agencies), payers, and the biopharmaceutical industry. Epidemiologic methods will be reviewed in the context of pharmaceutical, biotechnology and medical device evaluation. Study designs and data sources used to evaluate drug safety and effectiveness will be discussed using real-world examples. Special attention will be paid to methodological issues, such as confounding by indication, forms of selection and information bias that are unique to pharmacoepidemiologic research. Finally, select special topics are covered, including: risk-benefit analysis, clinical outcomes assessment, and comparative effectiveness research. Students will integrate the methods and operational principles discussed in class into a group presentation, which proposes and defends a study design to address post-approval safety and effectiveness concerns of a hypothetical new drug.