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Session 1: Real World Evidence: Examples of Today and Tomorrow
Session Chair(s)
Nevine Zariffa
Vice President and Head Biometrics & Information Sciences, Astrazeneca Pharmaceuticals, United States
Mark Levenson, PHD
Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER, FDA, United States
Electronic medical data systems and other healthcare data sources have the potential to enhance our understanding of medical interventions. While the randomized clinical trial continues to have an established place in the realm of evidence generation, these new data sources also warrant recognition. In this session, clinical, bioinformatic, statistical, and epidemiological experts will address how these data sources can be used to provide real world evidence to address clinical and regulatory questions. Speakers will address how real-world evidence can most productively be used in the short term and more ambitious uses in the future, as well, the challenges to making this happen.
Speaker(s)
Alec Walker, DrPH, MD
Drug Safety Epidemiologist, World Health Information Science Consultants, United States
Human-machine Synergy for Effective Classification of Health and Health Events
Amy Abernethy, MD, PHD
President of Clinical Studies Platforms, Alphabet’s Verily, United States
Oncology Real-World Evidence in Action: What Does it Take to Make the Promise of RWE a Reality?
Frank Shen, PHD
Retired Vice President, Data and Statistical Sciences, GPRD, Abbvie, Inc., United States
Differentiating Real-World Information Versus Real-World Evidence
Jonathan P. Jarow, MD, PHD
Chief Medical Officer, ODE, CDRH, FDA, United States
Use of Real World Evidence in Regulatory Decision-Making: FDA Perspective
Q&A Panel Discussion
, United States
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