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
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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.
- : 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.
- : Application (July 17–18, 2018) examined approaches for operationalizing the collection and use of real-world evidence.
The objectives of the workshops were to: