Overview of the Current Real-World Evidence Regulatory Landscape

Rima Izem (), Ruthanna Davi, Jingyu Julia Luan and Margaret Gamalo
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Rima Izem: Statistical Methodology, Novartis Pharma AG
Ruthanna Davi: Data Science, Medidata AI
Jingyu Julia Luan: Regulatory Affairs, AstraZeneca
Margaret Gamalo: Global Biometrics, Pfizer

A chapter in Real-World Evidence in Medical Product Development, 2023, pp 17-28 from Springer

Abstract: 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.

Keywords: Real-world evidence; Real-world data; Fit-for-purpose; Regulatory guidance; Regulatory precedent (search for similar items in EconPapers)
Date: 2023
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-031-26328-6_2

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DOI: 10.1007/978-3-031-26328-6_2

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