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Session 9: Special Populations’ Perspectives on RWD and RWE
Session Chair(s)
Rachele Hendricks-Sturrup, DrSc, MA, MSc
Research Director, Real-World Evidence
Duke-Robert J. Margolis, MD, Center for Health Policy, United States
Real-world data is of increasing interest and utility to medical product regulators seeking to observe and monitor treatment outcomes among patients in the real world. This is especially given that clinical trial settings are least reflective of typical settings in which clinically and socio-demographically diverse patients are monitored and treated. In addition, patients with rare diseases must often rely on real-world data to supplement, inform, or drive clinical trials with potential to substantiate timely and potentially life-saving therapies. This session will describe how real-world data is used by regulators to inform clinical trials and post-market strategies, generate insights around social determinants of health, and monitor outcomes in rare disease patients and populations underrepresented in clinical trials.
Learning Objective :
- Describe how real-world data is used to generate insights about social determinants of health and inform clinical trial and post-market strategies
- Discuss regulatory uses of real-world data to observe and monitor outcomes in populations that are underrepresented in clinical trials but commonly treated in the real world
- Demonstrate uses of real-world data sources reflective of and to serve rare disease populations
Speaker(s)
RWD and SDOH Generating Insights from Clinical Trials to Post Market Strategies
Jennifer Lamppa, PhD
Inovalon, United States
Associate Vice President, Clinical Analytics
Optimizing Real-World Evidence in Rare Disease Registries
Victoria Hodgkinson, PhD
Lumiio Inc., Canada
Chief Scientific Officer
Regulatory Use of Real-World Data: Quantifying Drug Exposure Risk in Pregnancy with Retrospective Administrative Claims Data
Elizabeth Packnett, MPH
Merative, United States
Lead Researcher, Real World Data Research & Analytics