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Outcomes Standardization: An Imperative to Value Assessments
Session Chair(s)
Richard Gliklich, MD
Chief Executive Officer
OM1, United States
Data from both premarket and postmarketing clinical trials and formal registries of medical products can be used to assess safety and effectiveness across the medical product life cycle. Sources outside of clinical trials, such as EHRs, can provide evidence of continued effectiveness when used in larger populations in the postmarketing setting. However, the lack of consistent outcome assessments is a potential barrier to evaluating safety and efficacy across the continuum of the product life cycle.
Learning Objective : Discuss the gaps and challenges in the current environment resulting from a lack of outcomes standardization.
Speaker(s)
Standardizing Outcomes for Patient Registries: Early Results From the Outcome Measures Framework Pilot Test
Elise Berliner, PhD
Oracle Life Sciences, United States
Global Senior Principal for Real World Evidence Strategy
Panelist
Paul Stang, PhD, FISPE
Janssen Research & Development, LLC, United States
Vice President: Global Epidemiology
Panelist
John H. Powers, MD, FACP
George Washington University School of Medicine, United States
Professor of Clinical Medicine
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