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Overview of the Current Real-World Evidence Regulatory Landscape

In: Real-World Evidence in Medical Product Development

Author

Listed:
  • Rima Izem

    (Statistical Methodology, Novartis Pharma AG)

  • Ruthanna Davi

    (Data Science, Medidata AI)

  • Jingyu Julia Luan

    (Regulatory Affairs, AstraZeneca)

  • Margaret Gamalo

    (Global Biometrics, Pfizer)

Abstract

This chapter will review existing guidance documents and precedents related to real-world evidence provided by major regulatory agencies across the world. We will first outline the key concepts underpinning evaluation of real-world evidence and discuss similarity and differences in those concepts in guidance documents from different countries. Then, we illustrate the regulatory practice of using real-world data throughout the product development life cycle. This includes supporting clinical trial planning, safety evaluation, use as an external control to a single arm study, and supporting extrapolation from one population to another.

Suggested Citation

  • Rima Izem & Ruthanna Davi & Jingyu Julia Luan & Margaret Gamalo, 2023. "Overview of the Current Real-World Evidence Regulatory Landscape," Springer Books, in: Weili He & Yixin Fang & Hongwei Wang (ed.), Real-World Evidence in Medical Product Development, pages 17-28, Springer.
    • Handle: RePEc:spr:sprchp:978-3-031-26328-6_2
    DOI: 10.1007/978-3-031-26328-6_2
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