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The Need for Improved Access to FDA Reviews
Alec B. O’Connor, MD, MPH
JAMA. 2009;302(2):191-193.
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The medical literature is expanding rapidly, with thousands of new studies published each year. Increasingly, clinicians and scientists rely on rigorous syntheses of the scientific literature, such as high-quality systematic reviews and meta-analyses, which the Oxford Centre for Evidence-Based Medicine considers the highest level of scientific evidence available.1 However, systematic reviews and meta-analyses are typically based on the published literature, which is known to be biased,2-4 creating an important question: can we trust the highest level of evidence available in MEDLINE?
Unlike clinicians, academic investigators, and the public, the US Food and Drug Administration (FDA) and other regulatory agencies do not rely on the published literature as the primary source of data for making regulatory decisions. Instead, companies seeking drug or device approval must submit the raw data from pivotal randomized clinical trials (RCTs) and summaries of other relevant studies they have conducted to the . . . [Full Text of this Article] Clinical Trial Registration: Benefits and Limitations
Author Affiliations: Hospital Medicine Division, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.
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