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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)
Human-machine Synergy for Effective Classification of Health and Health Events
Alec Walker, DrPH, MD
World Health Information Science Consultants, United States
Drug Safety Epidemiologist
Oncology Real-World Evidence in Action: What Does it Take to Make the Promise of RWE a Reality?
Amy Abernethy, MD, PhD
Alphabet’s Verily, United States
President of Clinical Studies Platforms
Differentiating Real-World Information Versus Real-World Evidence
Frank Shen, PhD
Abbvie, Inc., United States
Retired Vice President, Data and Statistical Sciences, GPRD
Use of Real World Evidence in Regulatory Decision-Making: FDA Perspective
Jonathan P. Jarow, MD, PhD
FDA, United States
Chief Medical Officer, ODE, CDRH
Q&A Panel Discussion
United States