The course will focus on substantive topics in pharmacoepidemiology, including relevant principles of pharmacology, inference from spontaneous case reports, study design considerations, pre-marketing pharmacoepidemiology, common data sources for pharmacoepidemiological studies, drug utilization review, adherence, and the development, implementation, and assessment of therapeutic risk management policies.
Large longitudinal healthcare databases have become important tools for studying the utilization patterns and clinical effectiveness of medical products and interventions in a wide variety of care settings and for evaluating the impact of clinical programs or policy changes. Strengths and limitations of large longitudinal healthcare databases that are commonly used for research will be considered. Special attention will be devoted to nationally representative databases that are critical for comparative effectiveness research and local electronic medical record data sources that are readily available to new investigators.
Practical issues in obtaining, linking, and analyzing large databases will be emphasized throughout the course, and key analytic issues will be addressed.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Clinical Research, Drug Safety, and Pharmacovigilance.