Management of ADR Data from Different Sources

Abstract

The various sources from which pharmaceutical companies receive adverse drug reaction (ADR) data on their products will be considered. They include clinical trials premarketing (Phase I-III), post-marketing (Phase IV), spontaneous reports (own country, overseas reports), regulatory authority reports, post-marketing surveillance schemes (formal), and published literature. Data from these sources can be very different both in terms of quality and quantity, and this presents problems in its management. The approaches adopted by the Drug Surveillance Department in Glaxo Group Research will be described, but many will be applicable to the pharmaceutical industry in general. A pragmatic approach influenced by resources and available computer hardware and software has been adopted, and procedures have developed in response to such availability. Efforts have been made to limit the number of different databases employed.