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Aggregated Clinical Safety Evaluation Utilizing Real-World Data and Randomized Clinical Trial for Safety Decision Making
Session Chair(s)
Li-An Lin, PHD
Associate Principal Biostatistician, Merck & Co., Inc., United States
Aggregated clinical safety evaluation is a continual and iterative process. Well-designed observational study and advanced statistical analysis in integrating randomized clinical trials (RCTs) and real-world data (RWD) can be used to answer regulatory safety question, both pre- and post- marketing.
Learning Objective : Describe the potential role for randomized clinical trials (RCTs) and real-world data (RWD) in safety decision-making; Discuss the opportunities and challenges in aggregated clinical safety evaluation with both real world and clinical trial data sources.
Speaker(s)
Ranjeeta Sinvhal, MD
Executive Medical Director, Medical Safety, AbbVie, United States
Industry Perspective
Li-An Lin, PHD
Associate Principal Biostatistician, Merck & Co., Inc., United States
Integrative Analysis of Randomized Clinical Trial and Real-World Study
Birol Emir, PHD
Adjunct Professor, Columbia University; Senior Director, Pfizer Inc, United States
Advanced Machine Learning Methods for Casual Inference
Walter Straus, DrMed, MD, MPH, FACP
Vice President, Safety and PV, Moderna, United States
Panelist
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