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The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision Making
Session Chair(s)
Iris Loew-Friedrich, DrMed
Executive Vice President and Chief Medical Officer
UCB SA, Belgium
Though the Randomized Controlled Trial (RCT) has been the trusted standard for generating high-quality evidence of medical product safety and efficacy, the need for more rapid and cost effective understanding of product effectiveness and safety in the real-world has given rise to the vision that draws on real-world evidence as well as that derived from more traditional clinical research applications.
In this DIAmond session, prominent thinkers on scientific evidence for support of biomedical decision-making will discuss our readiness to tap Real World Evidence (RWE) for safety and efficacy questions and then consider its uses for regulatory purposes. The benefits and challenges of using RWE to generate evidence of sufficient quality for decision making, following the concept of using fit-for-purpose research tools, will be examined.
This DIAmond session will stimulate new insights on our readiness for the next steps in the evolution of evidence generation using RWE.
Learning Objective : Discuss current uses of RWE in the medical product life cycle; Describe potential uses of RWE to improve the speed and cost effectiveness determining safety and effectiveness of medical products in real world use; Compare and contrast the strengths of RCT and RWE data as evidence for medical and regulatory decision making.
Speaker(s)
Panelist
Nancy A Dreyer, PhD, MPH, FISPE
Dreyer Strategies LLC, United States
Founder
Panelist
Robert J. Temple, MD
FDA, United States
Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER
Panelist
Alison Cave, PhD
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Safety Officer
Panelist
Brian Bradbury, DrSc, MA
Amgen, United States
Vice President, Center for Observational Research
Panelist
Stephanie Devaney, PhD
National Institutes of Health (NIH), United States
Deputy Director of the All of Us Research Program
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