Author Affiliation: Center for Drug Evaluation & Research, Food and Drug Administration, Rockville, Md.
ability of prospectively designed randomized trials to provide
unbiased, definitive evidence about the benefits and risks of
treatments in the population studied is not in doubt, certain critical
aspects of drug therapy, however, cannot be addressed by this method or
addressed as rapidly as physicians, patients, and the public would
like. In this issue of THE JOURNAL, 2 related
articles1,2 consider the potential value of other methods
of discovery of adverse consequences of drug use as well as the
beneficial effects of drugs, specifically through epidemiologic methods
and meta-analyses (systematic overviews) of data. These methods
unquestionably have a place in the assessment of drug treatments but,
as has been often pointed out, they must be used with care and
recognition of their limitations.
Temple R. Meta-analysis and Epidemiologic Studies in Drug Development and Postmarketing Surveillance. JAMA. 1999;281(9):841–844. doi:10.1001/jama.281.9.841
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