All Times EDT
Keywords: postmarket, safety monitoring, risk assessment
In addition to vigilant premarket review of drug efficacy and safety, the US Food and Drug Administration (FDA) conducts active postmarket surveillance of adverse outcomes associated with approved drugs. In the postmarket setting where approved drugs become available to a wide variety of patients than those in randomized trials, safety monitoring and risk assessment activities typically utilize information from large observational databases. Examples of such databases include electronic health records (e.g., FDA-Sentinel), administrative medical claims (e.g., Centers for Medicare & Medicaid Services) and registry data (e.g., Registry Assessment of Peripheral Interventional Devices). This presentation will provide a background on methodological considerations regarding design and analysis of postmarket drug safety and risk assessment research that aims to infer causal relationship between an approved drug and a safety outcome based on RWD.