Real-World Evidence On Demand Training

This on-demand 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.

This on-demand course takes an average of 3.25 hours to complete. Learners have access to the course for one year from the date of purchase.

• The evolving  regulatory landscape
• Evolving real-world data: it's uses and determining when it is "fit for purpose"
• External comparator analyses
• Considering real-world evidence (RWE) in the context of an integrated package of evidence

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

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