Overview

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This short course will provide an overview of how real-world evidence is being used today for evidence generation in major markets. The primary focus is evidence generation for regulatory use, with a particular focus on comparative effectiveness, but the approaches described here are useful for health technology assessments for payers. Following the major points identified by the FDA in the Frameworks document released in December 2019, we will explain how the fitness of evidence from real-world data are assessed for any use case, key elements of design and analysis, and the current status of FDA guidance on when real-world studies will be sufficient to meet regulatory evidence requirements, including highlights from the recent draft guidance documents in 2021. Although much of the focus will be on FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data.

Who should attend?

Professionals involved in or interested in learning about real-world evidence, real-world data, epidemiology, clinical research, regulatory and technology development.

Learning objectives

At the conclusion of this short course, participants should be able to:

Discuss how regulators are using RWE for regulatory decision support
Describe the concept of RWE being “fit for purpose” including the importance of relevant data and methodologic rigor
Identify how RWE can be assembled and integrated to generate a compelling message

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Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use

Overview

Who should attend?

Learning objectives

Be informed and stay engaged.