Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series
||February 6, 2019
Report at a Glance
- Workshop series highlights
Note: Proceedings contain the opinion of the presenters, but do NOT reflect the conclusions of the Health and Medicine Division or the National Academies. Learn more about the differences between Reports and Proceedings.
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The Forum convened a three-part workshop series, sponsored by the FDA, examining how real-world evidence development and uptake could enhance medical product development and evaluation. The workshops advanced discussions and common knowledge about complex issues relating to the generation and use of real-world evidence, including fostering development and implementation of the science and technology of real-world evidence generation and utilization.
- Workshop One: Incentives (September 19-20, 2017) focused on how to align incentives to support the collection and use of real-world evidence in medical product review, payment, and delivery, including incentives needed to address barriers impeding the uptake of real-world evidence, such as transparency.
- Workshop Two: Practical Approaches (March 6–7, 2018) was a “town-hall” style meeting with in-depth audience discussion and active participation to illuminate which types of data may be appropriate for specific purposes and discuss practical approaches for data collection and evidence use.
- Workshop Three: Application (July 17–18, 2018) examined approaches for operationalizing the collection and use of real-world evidence.
The objectives of the workshops were to: