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Session 2: Non-Interventional Studies: Study Design Considerations and Current Applications
Session Chair(s)
Brian Bradbury, DrSc, MA
Vice President, Center for Observational Research
Amgen, United States
This session is designed to provide you with a general understanding of key design and analytic principles for non-interventional studies evaluating treatment effects. The session will present examples of high-quality non-interventional studies designed to evaluate the effectiveness and safety of therapeutic interventions and discuss key sources of bias and approaches to handling them.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify key design and analytic considerations for conducting non-interventional studies to evaluate drug effectiveness and safety
- Identify examples of high-quality non-interventional studies
- Identify key sources of bias in non-interventional studies and approaches to addressing them
Speaker(s)
Real World Data Analyses: Causal Study Designs
Sebastian Schneeweiss, DrSc, MD
Harvard Medical School and Brigham and Women's Hospital, United States
Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology
Non-Interventional Studies: Study Design Considerations and Current Applications
David T Gilbertson, PhD
Chronic Disease Research Group, United States
Co-Director
Non-Interventional Studies: Study Design Considerations and Current Applications
Alan Brookhart
University of North Carolina, Chapel Hill, United States
Professor, Department of Epidemiology, Gillings School of Global Public Health