Abstract:
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Evaluating the benefit-risk of medical devices in clinical trials can be difficult task, because the benefit and risk are two distinct variables. While in some cases benefit and risk have the same unit, in general, they are measured in different unit. For example, in the atrial fibrillation ablation studies, preventing or reducing unwanted electrical currents from traveling from the pulmonary veins (large blood vessels that carry blood from the lungs to the left atrium of the heart) to the atria (the upper chambers of the heart) will be considered as benefit, and any major adverse events may be used to assess the risk. In this talk, we propose measures for simultaneously assessing benefits and risks in medical device clinical trials.
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