February 20, 2018: National Academies Release Workshop Summary on Real-World Evidence in Medical Product Development

The National Academies of Sciences, Engineering, and Medicine released a summary of the first workshop in a 3-part series on the development and use of real-world evidence in medical product development. The report, Examining the Impact of Real-World Evidence on Medical Product Development: I. Incentives, focuses on the role of incentives in supporting the collection and use of real-world evidence in product review, payment, and delivery.

In clinical research, data from observational studies, registries, claims, safety surveillance, and other sources are increasingly recognized as valuable supplements to randomized controlled trials. The 3-part workshop, sponsored by the US Food and Drug Administration, is intended to “advance discussions and common knowledge about complex issues relating to the generation and utilization of real-world evidence.”

NIH Collaboratory investigators Dr. Gregory Simon and Dr. Richard Platt served on the planning committee for the workshop series. Dr. Simon opened Workshop 1 by summarizing the core qualities of real-world evidence. Dr. Platt presented lessons from the Sentinel Initiative, an example of the successful use of real-world evidence to answer questions of efficacy and effectiveness.

The second workshop in the series, “Practical Approaches,” will explore what types of data are appropriate for which purposes and will recommend practical approaches for data collection. Registration for Workshop 2 is open now.