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Source: American Heart Journal
Condition: Heart Attack
Drug: Avandia
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Total 2 results found since Jan 2013.
Methodology of a reevaluation of cardiovascular outcomes in the RECORD trial: Study design and conduct
Conclusions: Comprehensive procedures were used for rigorous event reascertainment and readjudication in a previously completed open-label, global clinical trial. These procedures used in this unique situation were consistent with other common approaches in the field, were enhanced to address the FDA concerns about the original RECORD trial results, and could be considered by clinical trialists designing event readjudication protocols for drug development programs that have been completed.
Source: American Heart Journal - June 24, 2013 Category: Cardiology Authors: Renato D. Lopes, Sheila Dickerson, Gail Hafley, Shana Burns, Sandra Tourt-Uhlig, Jennifer White, L. Kristin Newby, Michel Komajda, John McMurray, Robert Bigelow, Philip D. Home, Kenneth W. Mahaffey Tags: Trial Design Source Type: research
