Bayesian Methods in Pharmacovigilance

Regulators such as the U.S. Food and Drug Administration have elaborate, multi-year processes for approving new drugs as safe and effective. Nonetheless, in recent years, several approved drugs have been withdrawn from the market because of serious and sometimes fatal side effects. We describe statistical methods for post-approval data analysis that attempt to detect drug safety problems as quickly as possible. Bayesian approaches are especially useful because of the high dimensionality of the data, and, in the future, for incorporating disparate sources of information.