Applications Using Real-World Evidence to Accelerate Medical Product Development

Weili He (), Tae Hyun Jung, Hongwei Wang and Sai Dharmarajan
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Weili He: Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie
Tae Hyun Jung: Office of Biostatistics, CDER, Food and Drug Administration
Hongwei Wang: Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie
Sai Dharmarajan: Office of Biostatistics, CDER, Food and Drug Administration

A chapter in Real-World Evidence in Medical Product Development, 2023, pp 365-386 from Springer

Abstract: Abstract As the use of real-world evidence (RWE) and real-world data (RWD) continuously evolves, the strategic planning and tactical implementation is becoming multifaceted and should be considered with the real application setting in mind. In this chapter, we describe a few real examples that regulatory agencies considering the use of RWE/RWD for regulatory decisions. For each case study, where information is available in the public domain, we summarize the clinical and real-world (RW) study background and provide our analysis on following aspects: the regulatory contexts, whether the use of RWE/RWD is pivotal or supplemental for the regulatory decisions, the regulatory quality data sources, statistical methods employed, settings where the approvals were obtained or denied, and any regulatory opinions for the submission and regulatory decision. These useful case studies will provide important learning for future applications.

Keywords: Real-world data; Real-world evidence; Case study; Fit-for-purpose; Data relevancy; Data reliability; Best practice; Lessons learned (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_19

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DOI: 10.1007/978-3-031-26328-6_19

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