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Activity Number: 150
Type: Invited
Date/Time: Monday, August 5, 2013 : 10:30 AM to 12:20 PM
Sponsor: Health Policy Statistics Section
Abstract - #307394
Title: Use and Misuse of Observational Data: The Critical Importance of Sound Study Design
Author(s): Allen Heller*+
Companies: Bayer HealthCare Pharmaceuticals
Keywords: Observational Studies ; Propensity Score Design ; Aprotinin ; Causal Inference ; Covariate Balance
Abstract:

Observational data are frequently used in an effort to compare the safety of marketed drugs. Aprotinin, a drug approved in many countries for administration to coronary artery bypass [CABG] patients to reduce bleeding and the need for transfusion, was removed from the worldwide market in 2007. This occurred, in part, in reaction to several published reports of observational studies, some concluding that aprotinin was associated with a higher risk of mortality compared with no treatment or alternative treatments. Following extensive review of the data, Canada restored aprotinin to the market in 2011, and the EMA recommended marketing reinstatement in the European Union in 2012. This presentation will highlight, in the context of proper study design, the reasons for the disparity in the reported conclusions from observational studies involving aprotinin. Those observational studies that were properly designed, consistent with results of randomized trials, gave no evidence for an increased risk of mortality caused by aprotinin.


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