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Title: Estimating treatment effects for individual patients using randomized controlled trials: Opportunities to rethink how we treat and define diseases? Speakers: Dr. Michael Harhay & Dr. Patrick Lawler MUHC Hybrid Medical Grand Rounds Sept.23, 2025 at 12h00-13h00 Educational objectives: 1. Understand heterogeneous treatment effects in randomized controlled trials and their clinical implications. 2. Develop familiarity with modern statistical methods to identify differential treatment responses across patient subgroups in clinical trials including the estimation of individualized treatment effects. 3. Considering emerging clinical trial designs built around these frameworks. Biosketch of Dr. Michael Harhay, Bayesian Biostatistician and Associate Professor, University of Pennsylvania: Dr. Michael Harhay specializes in the statistical design, analysis, and interpretation of large randomized trials and cohort studies. He has been formally involved in more than 20 randomized trials to date and has particular research interests in many of the most challenging topics in the design and analysis of contemporary trials, including (composite) outcome measure development and interpretation, methods for missing outcome data, health-system embedded and pragmatic cluster-randomized designs, Bayesian and adaptive trial methods, and applications of causal inference methods to augment the interpretation of randomized (experimental) data. Biosketch of Dr. Patrick Lawler, Clinician-Scientist and Associate Professor, McGill University and University of Toronto: Dr. Patrick Lawler is director of the Cardiac Intensive Care Unit at the McGill University Health Centre in Montreal, and also a staff cardiologist at Toronto General Hospital in Toronto, both in Canada. He is an Associate Professor of Medicine at McGill University and the University of Toronto. His research employs Bayesian adaptive platform randomized clinical trials, clinical epidemiology, and translational methods. He has a focus on methods to identify heterogeneity of treatment effect in clinical trials. He has led randomized clinical trials in acutely/critically ill patients, and has also supported the design and implementation of others. His research has been funded by greater than $35M from the Canadian Institutes of Health Research, the U.S. National Institutes of Health, philanthropy, and others, and has been published in the New England Journal of Medicine, JAMA, the European Heart Journal, Circulation, Intensive Care Medicine, Critical Care Medicine, and elsewhere. He is the chief medical officer at Sparked Inc., an early-stage Toronto-based microfluidic diagnostic company. He serves on executive committees for the American Heart Association and as the inaugural associate editor for cardiac critical care for the American College of Cardiology's open access journal JACC: Advances.