Epidemiologists and adverse event data - A challenge to the field

Spontaneous adverse event reports, albeit biased and incomplete data, remai n very important and, frequently, are the sole data source to rely on durin g the postmarketing phase for regulatory decision making. However, little p rogress has been made in the past decade to improve the utility of these es sential data. Further research that helps to improve our understanding of t he extent and characteristics of adverse event reporting should be done to ensure the maximum, appropriate utilization of this highly cost-efficient d ata source. In addition, the authors challenge that research can and should be done to advance our understanding of the behaviour and motivations of t hose who report adverse events so as to improve the quality and the quantit y of meaningful spontaneous adverse event reports. Copyright (C) 1999 John Wiley & Sons, Ltd.