Collection of papers on Real-World Evidence from the National Academies workshop series

July 2, 2021

The National Academies of Sciences, Engineering, and Medicine convened a three-part workshop series, sponsored by the U.S. Food and Drug Administration, 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 utilization of real-world evidence, including fostering development and implementation of the science and technology of real-world evidence generation and utilization.

  • Workshop One (September 19–20, 2017) focused on how to align incentives to support collection and use of real-world evidence in health product review, payment, and delivery. Incentives need to address barriers impeding the uptake of real-world evidence, including barriers to transparency. 
  • Workshop Two (March 6–7, 2018) was a “town-hall” style meeting with active audience participation to illuminate what types of data are appropriate for what specific purposes and to suggest approaches for data collection and evidence use by developing and working through example use cases.
  • Workshop Three (July 17–18, 2018) examined and suggested approaches for operationalizing the collection and use of real-world evidence. 

Below are materials for the workshop, including an agenda, briefing book, and presentations. View archived webcast footage of the presentations and discussions here.

For additional information on the workshop, including the planning committee and sponsors, please visit our project page.

In June 2021, some individual workshop speakers and attendees published a set of 4 journal articles inspired by what they learned at this workshop series and taking into account lessons learned from the COVID-19 pandemic. Links to the open access articles published in Clinical Pharmacology & Therapeutics are below:

Collection of papers on Real-World Evidence from the National Academies workshop series