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Meta-analysis and Epidemiologic Studies in Drug Development and Postmarketing Surveillance
Robert Temple, MD
JAMA. 1999;281:841-844.
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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.
Meta-analyses
Berlin and Colditz1 consider the potential uses of meta-analyses, primarily meta-analyses of controlled trials, in the approval and postmarketing evaluation of Food . . . [Full Text of this Article] Meta-experiments. Post hoc Meta-analyses. Discovery of Adverse Effects. Limitations of Epidemiologic Studies. Alternative Approaches.
Author Affiliation: Center for Drug Evaluation & Research, Food and Drug Administration, Rockville, Md.
RELATED ARTICLES
Postmarketing Surveillance and Adverse Drug Reactions: Current Perspectives and Future Needs
Timothy Brewer and Graham A. Colditz
JAMA. 1999;281(9):824-829.
ABSTRACT
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The Role of Meta-analysis in the Regulatory Process for Foods, Drugs, and Devices
Jesse A. Berlin and Graham A. Colditz
JAMA. 1999;281(9):830-834.
ABSTRACT
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