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Pharmacoepidemiol Drug Saf. 1999 Oct;8(6):457-61.

Epidemiologists and adverse event data--a challenge to the field.

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Berlex Laboratories Inc., 340 Changebridge Road, Pine Brook, New Jersey 07058, USA.


Spontaneous adverse event reports, albeit biased and incomplete data, remain very important and, frequently, are the sole data source to rely on during the postmarketing phase for regulatory decision making. However, little progress has been made in the past decade to improve the utility of these essential data. Further research that helps to improve our understanding of the extent and characteristics of adverse event reporting should be done to ensure the maximum, appropriate utilization of this highly cost-efficient data source. In addition, the authors challenge that research can and should be done to advance our understanding of the behaviour and motivations of those who report adverse events so as to improve the quality and the quantity of meaningful spontaneous adverse event reports.

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