Follow-Up Studies

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Chapter: Pharmacovigilance: Keynote Clinical Lessons from Pharmacovigilance

In the era before large automated data sets became available for pharmacoepidemiology research, a number of ad hoc studies were mounted to look at the safety aspects of specific drugs.


FOLLOW-UP STUDIES

In the era before large automated data sets became available for pharmacoepidemiology research, a number of ad hoc studies were mounted to look at the safety aspects of specific drugs. These studies had undoubted problems, and were generally expen-sive to mount and to conduct. Nonetheless they served to provide quantitation for several interest-ing risks, refute others, and they also helped to improve our understanding of methodology in this arena. They were, however, reported as being unhelp-ful to members of the UK Medicines Control Agency in their periodic safety assessments of licenced medicines (Waller et al., 1992; 304: 1470–2). Perhaps regulators should generally remain aloof from issu-ing guidance on methodology until such time as the issues are clear-cut and generally accepted by experts within the field. We are now left with the main source of information in this area being the multipurpose databases.

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