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Session 2: Observational Studies and Beyond
Session Chair(s)
Aloka Chakravarty, PhD
Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Brenda Crowe, PhD
Associate Vice President, Statistics
Eli Lilly and Company, United States
This session will highlight various roles observational studies play in regulatory decision making. It will discuss a Bayesian approach to sensitivity analysis for unmeasured confounding. It will also give a very high-level overview of mini-Sentinel and what it can bring. The focus will be on challenges in using these kinds of systems for prospective safety surveillance. Case examples for the Bayesian approach and for challenges of mini-Sentinel will be presented.
Speaker(s)
Unmeasured Confounding Sensitivity Analyses
James Stamey
Baylor University, United States
Director, Statistical Science Graduate Studies
Methodological Challenges in Conducting Post-licensure Drug and Vaccine Safety Surveillance Using Large Electronic Healthcare Databases
Jennifer Clark Nelson
Group Health Research Institute, United States
Senior Investigator & Director of Biostatistics
Speaker
Robert Ball, MD, MPH, MSc
FDA, United States
Deputy Director, Office of Surveillance and Epidemiology, CDER
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