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ON DEMAND - What Makes Real World Data Trustworthy: A Focus on Design and Data
Session Chair(s)
Nancy A Dreyer, PHD, MPH, FISPE
Founder
Dreyer Strategies LLC, United States
An number of on-going activities are examining real world data (RWD) and comparing it to data from randomized clinical trials in order to gauge whether the RWD are trustworthy and if they could be a substitute. Although useful to understand these measures, this approach ignores the unique contribution of RWD, particularly in the context of when it can be used to speed access to medical innovations, to understand comparative effectiveness and safety and the the implications of real-world adherence as well as characterize benefits and risks over longer periods of follow-up than are typical for most trials, particularly.
As regulators around the world become more interested in using RWD, current efforts in the US, Europe, and Japan will be discussed along with what they are requesting to provide comfort with the data methods and evidentiary requirements.
Learning Objective : Discuss current efforts in the US, Europe, and Japan with using real world data to speed access to medical innovations, understand comparative effectiveness, and safety.
Speaker(s)
FDA Update
Peter Stein, MD
Peter Stein Consulting, LLC, United States
Consultant
PMDA Update
Yoshiaki Uyama, PHD, MS, RPH
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director