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This 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. Although much of the focus will be on the FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data.

An additional registration fee is required for all preconference short courses.

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Who should attend?

This short course is designed for members of the Clinical Research and Regulatory audiences.

Learning objectives

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

  • Describe key epidemiological design principles central to interpreting the quality and validity of RWE studies;
  • Apply these learnings by evaluating and discussing case presentations focused on CV safety assessments;
  • Recognize when RWE based approaches are of sufficient quality to enable decision making.

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