Clinical Research Issues Forum: The Avandia controversy: A broken RECORD?
Oct 31, 2014 (Fri) | 12:30 PM -1:45 PM
MSOB X303
: Stanford, CA
The cardiovascular safety of rosiglitazone (Avandia™) has been hotly debated, despite extensive study. Following an FDA Advisory Committee that noted concerns about the RECORD trial, the FDA required GlaxoSmithKline, the trial sponsor, to commission a reevaluation of the deaths and cardiovascular endpoints in the trial. The process used to perform that reevaluation, the recently reported results of that effort, and the interactions with the FDA will be presented and discussed.
Department: Health Research & Policy - Epidemiology
Contact: Tammi Nicosia | 650-721-5788 | nicosia@stanford.edu
Presenter(s):
- Ken Mahaffey, M.D. Professor, Stanford Univiersity SoM
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