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DIA 2021 Global Annual Meeting


Aggregated Clinical Safety Evaluation Utilizing Real-World Data and Randomized Clinical Trial for Safety Decision Making

Session Chair(s)

Li-An  Lin, PhD

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

Industry Perspective

Ranjeeta Sinvhal, MD

  • Group Medical Director, Medical Safety Evaluation
  • AbbVie, United States
Li-An  Lin, PhD

Integrative Analysis of Randomized Clinical Trial and Real-World Study

Li-An Lin, PhD

  • Associate Principal Biostatistician
  • Merck & Co., Inc., United States
Birol  Emir, PhD

Advanced Machine Learning Methods for Casual Inference

Birol Emir, PhD

  • Adjunct Professor, Columbia University; Senior Director
  • Pfizer Inc, United States
Walter  Straus, DrMed, MD, MPH, FACP

Panelist

Walter Straus, DrMed, MD, MPH, FACP

  • Vice President, Safety and PV
  • Moderna, United States