SCRIP Regulatory Affairs: Fatal flaws of trial designs: Nissen explains

If ever anyone wanted to "screw up a safety study," GlaxoSmithKline's RECORD trial, which assessed cardiovascular outcomes after the addition of Avandia (rosiglitazone) to either metformin or sulfonylurea, "was the perfect example," charged Dr Steven Nissen, chairman of cardiology medicine at the Cleveland Clinic Foundation in Ohio.

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