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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

Results of a reevaluation of cardiovascular outcomes in the RECORD trial
Conclusions: Only a modest number of additional person-years of follow-up were ascertained from this reevaluation of CV end points in RECORD. Observed HRs and CIs from these analyses using the original RECORD or new FDA end point definitions showed similar treatment effects of rosiglitazone compared with the original RECORD results.
Source: American Heart Journal - June 6, 2013 Category: Cardiology Authors: Kenneth W. Mahaffey, Gail Hafley, Sheila Dickerson, Shana Burns, Sandra Tourt-Uhlig, Jennifer White, L. Kristin Newby, Michel Komajda, John McMurray, Robert Bigelow, Philip D. Home, Renato D. Lopes Tags: Diabetes and Metabolism Source Type: research

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 - October 20, 2014 Category: Cardiology Source Type: research

Results of a reevaluation of cardiovascular outcomes in the RECORD trial
Conclusions Only a modest number of additional person-years of follow-up were ascertained from this reevaluation of CV end points in RECORD. Observed HRs and CIs from these analyses using the original RECORD or new FDA end point definitions showed similar treatment effects of rosiglitazone compared with the original RECORD results.
Source: American Heart Journal - October 20, 2014 Category: Cardiology Source Type: research