FDA's Marciniak vs. Unger: Cardio Experts Divided On GSK's RECORD Study
FDA's internal disagreements about the value of GlaxoSmithKline's RECORD trial stem, in part, from different visions of the role agency reviewers should play in analyzing data
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Flawed clinical trial overcomes meta-analysis safety signal as mortality data from the re-adjudicated RECORD trial persuades the rosiglitazone advisory committee that the product’s risk management program can be relaxed.
The agency reiterates its commitment to protecting scientific integrity in response to the Union of Concerned Scientists’ survey of FDA scientists; staff cite corporate influence on agency decisions and fear of retaliation for expressing their concerns.