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When is Real World Evidence Ready for Prime Time?
Session Chair(s)
Nancy A Dreyer, PHD, MPH, FISPE
Founder
Dreyer Strategies LLC, United States
We see growing interest in the value of using real world data (RWD) to support label expansions and approvals of drugs for rare conditions and oncology products. The FDA released its Framework for Real World Evidence Program in December 2018, following release of the its MyStudies App designed to incorporate patient-originated data with other RWD for research purposes. In Europe, the Heads of Medicines Agencies and the European Medicines Agency released a joint report in February, 2019 on their big data taskforce summarizing many areas of interest to better understand RWD and its possible uses. We will distill key lessons from demonstration projects and other experience to understand what is being done to evaluate data sets to give confidence in a RW study design, and its findings, including the challenges encountered when comparing data from clinical trials with a medicine’s performance in routine clinical practice, as actually prescribed by physicians and taken by patients.
Learning Objective : Describe at least one innovative study design that used real world data for label expansion; Characterize the types of diseases and treatments for which real world evidence has been used to expand the labeled use.
Speaker(s)
FDA Update
Peter Stein, MD
Peter Stein Consulting, LLC, United States
Consultant
EMA Update
Tony Humphreys, MPHARM
European Medicines Agency, Netherlands
Head of the Regulatory Science and Innovation Task Force
Panelist
Gregory Daniel, PHD, MPH
Eli Lilly and Company, United States
Vice President, Head of Public Policy Innovation and Evidence
Panelist
Solomon Iyasu, DrMed, MPH
Iyasu Epi-RWE Strategy LLC , United States
Principal