The Use of Costart at Burroughs Wellcome Company

Abstract

COSTART was chosen as the vocabulary for reporting adverse experiences from clinical trials at Burroughs Wellcome Company. Three major factors precipitated this decision: The Product Surveillance and Epidemiology Department had been using it for several years; our colleagues in the United Kingdom were coding reports on marketed drugs in COSTART for better comparability, and it met our preference for using broad terminology. An additional consideration was that it is the vocabulary developed by the Food and Drug Administration. A simple set of rules facilitates application of COSTART to clinical trial reports. When an investigational drug is marketed, the coding of adverse experiences in COSTART makes transfer of this information to the Department of Product Surveillance and Epidemiology easy. In the same way, foreign reports become comparable with those generated in this country.