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March 3, 1999

Meta-analysis and Epidemiologic Studies in Drug Development and Postmarketing Surveillance

Author Affiliations

Author Affiliation: Center for Drug Evaluation & Research, Food and Drug Administration, Rockville, Md.

JAMA. 1999;281(9):841-844. doi:10.1001/jama.281.9.841

The unmatched 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.