Methodologic Issues in Post-Marketing Surveillance: Pharmaceutical Industry's View—Burroughs Wellcome

Abstract

The program in pharmaco-epidemiology has been developed at Burroughs Wellcome Company coupling into a single department the monitoring of spontaneously reported adverse experiences (“epidemiologic intelligence”) with the design and conduct of epidemiologic studies, with primary emphasis upon monitoring for drug safety. The emphasis of the program is upon tailoring the epidemiologic method to meet the information need; and recognizing the uniqueness of each drug, each phase in the evolution of drug experience, and each specific set of questions to be answered. Examples are given of specific studies using varied epidemiologic methods and the specific sorts of questions they are designed to address within the Burroughs Wellcome program in pharmaco-epidemiology.