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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