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440 * ! Thu, 8/6/2020, 10:00 AM - 11:50 AM Virtual
Let’s Make Everyone and Everything Count! Benefit-Risk Assessment Challenges, Lessons and Impacts in the Age of Big Data from Clinical Trials to Real-World Evidence — Topic Contributed Papers
Biopharmaceutical Section, ENAR, Royal Statistical Society
Organizer(s): Shahrul Mt-Isa, Merck
Chair(s): Shahrul Mt-Isa, Merck
10:05 AM Individualized Treatment Choices and Benefit-Risk Prediction in Cardiovascular Clinical Trials
John Gregson; Ruth Owen, LSHTM; Stuart Pocock, LSHTM; Shahrul Mt-Isa, Merck; Richard Baumgartner, Merck
10:25 AM Do Birds of a Feather Flock Together? a Question of Credible Subgroup Identification and Inference on Benefitting Populations in Clinical Trials
Duy Ngo, Western Michigan University; Patrick Schnell, The Ohio State University College of Public Health; Richard Baumgartner, Merck; Shahrul Mt-Isa, Merck; Jie Chen, Merck & Co., Inc.; Dai Feng, AbbVie
10:45 AM Bayesian Bivariate Subgroup Analysis for Risk–benefit Evaluation
Nicholas C. Henderson, University of Michigan-Ann Arbor
11:05 AM Opportunities and Challenges of Real-World Data (RWD) in Benefit-Risk Assessment (BRA)
Emilie Scherrer, Merck & Co Inc
11:25 AM Everyone Counts - Regulating the Evidence from Clinical Trial Data to Real-World Evidence for the Public Good: The Past, Present, and Future
Lisa LaVange, UNC-CH
11:45 AM Floor Discussion