Despite earlier concerns by its editors about “data parasites,” the New England Journal of Medicine has now published 4 articles offering support in some form for data sharing. But two of the articles— written by many of the most prominent clinical trial researchers in the United States and Canada— express grave concerns about data sharing…
With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial
June 3, 2013 by Leave a Comment
The FDA today released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed…
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