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Benefit-Risk Tradeoffs in Assessment of New Drugs and Devices.
Abstract Balancing benefits and risks is a complex task that poses a major challenge, both to the approval of new medicines and devices by regulatory authorities and in therapeutic decision-making in practice. Several analysis methods and visualization tools have been developed to help evaluate and communicate whether the benefit-risk profile is favorable or unfavorable. In this White Paper, we describe approaches to benefit-risk assessment using qualitative approaches such as the Benefit Risk Action Team framework developed by the Pharmaceutical Research and Manufacturers of America, and the Benefit-Risk Framewor...
Source: Circulation - November 17, 2020 Category: Cardiology Authors: Kaul S, Stockbridge N, Butler J Tags: Circulation Source Type: research

Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Critical Evaluation of Clinical and Regulatory Issues.
This report summarizes these discussions and the key takeaway messages from this meeting. PMID: 31841369 [PubMed - in process]
Source: Circulation - December 16, 2019 Category: Cardiology Authors: Butler J, Packer M, Greene SJ, Fiuzat M, Anker SD, Anstrom KJ, Carson PE, Cooper LB, Fonarow GC, Hernandez AF, Januzzi JL, Jessup M, Kalyani RR, Kaul S, Kosiborod M, Lindenfeld J, McGuire DK, Sabatine MS, Solomon SD, Teerlink JR, Vaduganathan M, Yancy CW, Tags: Circulation Source Type: research