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Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series


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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:

  • Advance discussions and common knowledge among key stakeholders (including FDA and the public) about complex issues relating to the generation and utilization of real-world evidence.
  • Foster development and implementation of the science and technology of real-world evidence generation and utilization.

    The workshops addressed the following topics:

  • Definitions surrounding the core components of real-world evidence.
  • Sources of data that are curated, standardized, and analyzed to derive real-world evidence, such as safety surveillance, observational studies, registries, claims, or patient-centered outcomes research.
  • Gaps in data collection activities, and priority areas and pilot opportunities that real-world evidence incorporation could address.
  • Standards and methodologies for collecting and analyzing real-world evidence in support of new indications or post-approval studies, and the circumstances under which that evidence could be applied.
  • Applications for using real-world evidence to supplement traditional clinical trials, pragmatic/effectiveness trials, or routine clinical application.
  • Mechanisms for determining which discrete types of real-world evidence could support regulatory decisions.
  • Operational challenges and barriers for generating and incorporating real-world evidence in the context of a learning health system and how clinicians can best be involved in the collection and utilization of real-world evidence.

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