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Seeing the value in observational studies

Executive Summary

Safety signals identified in observational studies require confirmation but provide important information about drug use in a real-world setting, according to a pair of opinion pieces in the Nov. 23 issue of the New England Journal of Medicine; both articles addressed Bayer's failure to disclose a large observational study on its drug Trasylol before a recent advisory committee review (1"The Pink Sheet" Oct. 2, 2006, p. 25). "Although observational studies cannot be definitive...they can provide important new safety information that can direct further scientific and regulatory actions - if their findings can be confirmed," Cardio-Renal Drugs Advisory Committee chair William Hiatt (University of Colorado) said. Jerry Avorn (Harvard Medical School) advises care with application of epidemiological research techniques, and argues that transparency of study methods and raw data are critical to interpreting results that are confounded in such uncontrolled studies...

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