Role of Epidemiological Data Within the Drug Development Lifecycle: A Chronic Migraine Case Study

By definition, pharmacoepidemiology is the study of the use and the effects of drugs, medical devices or vaccines in large numbers of people (Strom, 1994). Epidemiologists working in the pharmaceutical and biotechnology industry use the principles of descriptive epidemiology in addition to analytical and clinical epidemiological applied concepts and methods to assess the impact, use and effects of these products in the population and in clinical trial settings. As an evolving field, the influence of pharmacoepidemiology continues to be broadened with increasing demands for a comprehensive understanding of the patient population within the development and post-authorization phases of a product’s lifecycle.