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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)
Industry Perspective
Ranjeeta Sinvhal, MD
AbbVie, United States
Executive Medical Director, Medical Safety
Integrative Analysis of Randomized Clinical Trial and Real-World Study
Li-An Lin, PhD
Merck & Co., Inc., United States
Associate Principal Biostatistician
Advanced Machine Learning Methods for Casual Inference
Birol Emir, PhD
Pfizer Inc, United States
Adjunct Professor, Columbia University; Senior Director
Panelist
Walter Straus, DrMed, MD, MPH, FACP
Moderna, United States
Vice President, Safety and PV
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