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Real-World Data to Real World Evidence for Assessing Efficacy and Effectiveness
Session Chair(s)
Lawrence Liberti, PhD, RAC
Director, D.K. Kim International Center for Regulatory Science
The Kim Center/ USC DRQS, United States
In the US and EU, there are opportunities and challenges for new medicines development, regulatory review, and health technology. The efficacy and effectiveness gap is challenging the value in decision making and the generalizability of findings from the traditional gold standard randomized controlled trials (RCT) to use of medicines outside of the studied population. Many decisions that need to be made by HTA agencies must rely on the RCT-generated evidence in their analysis and deliberations with respect to the expected effectiveness of new medicines.
Join Patient Engagement Community for a follow up Round Table discussion at 12:00pm in the Community Corner.
Learning Objective : Evaluate whether RWD can enable decision making by complementing evidence from RCTs using data from other sources, including observational studies, EHRs, claims databases, or other nonstandard information sources.
Speaker(s)
Using Real World Evidence and Real-World Data to Build Confidence in Regulatory Decision-Making
Jonathan P. Jarow, MD, PhD
FDA, United States
Chief Medical Officer, ODE, CDRH
Using Real World Evidence and Real-World Data to Inform New Indications and Build Confidence in a Development Plan
James Harnett, PharmD, MS
Regeneron Pharmaceuticals, Inc. , United States
Executive Director, Health Economics and Outcomes Research
How Various Stakeholders are Using or Thinking of Using Real World Evidence and Real-World Data to Inform Their Decisions
Jean Slutsky, MPH
Patient-Centered Outcomes Research Institute (PCORI), United States
Senior Advisor to the Executive Director
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