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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - What Makes Real World Data Trustworthy: A Focus on Design and Data

Session Chair(s)

Nancy A Dreyer, PhD, MPH, FISPE

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)

Peter P. Stein, MD

FDA Update

Peter P. Stein, MD

FDA, United States

Director, Office of New Drugs, CDER

Yoshiaki  Uyama, PhD, RPh

PMDA Update

Yoshiaki Uyama, PhD, RPh

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Associate Executive Director

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