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Addressing Heterogeneity of Real World Evidence in Drug Safety
Session Chair(s)
Michael Blum, MD, MPH
Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER
FDA, United States
This session addresses the concern of inconsistent real world evidence in drug safety by presenting 1) epidemiological approaches for assessing inconsistent findings in observational studies, 2) lessons learned from observational studies in a distributed research network and 3) challenges using methods that synthesize findings from observational studies.
Learning Objective : Identify possible study factors contributing to heterogeneity of real world evidence using claims databases; Discuss lessons learned from observational studies in a distributed research network regarding heterogeneity of RWE; Describe methods for synthesizing findings from observational studies and their limitations.
Speaker(s)
Epidemiological Approaches for Assessing Inconsistent Findings in Observational Studies
Huei-Ting Tsai, PHD, MS
FDA, United States
Epidemiologist, Office of Surveillance and Epidemiology, CDER
Minimizing Heterogeneity in Distributed Research Networks: Examples from the Canadian Network for Observational Drug Effect Studies
Adrian Levy, PHD, MSC
Dalhousie University, Canada
Professor, Department of Community Health and Epidemiology
Challenges with Methods Used to Synthesize Findings from Observational Studies
Alicia Gilsenan, PHD, MS, RPH, FISPE
RTI Health Solutions, United States
Vice President, Epidemiology