The Need for Real-World Evidence in Medical Product Development and Future Directions

Weili He (), Yixin Fang, Hongwei Wang and Charles Lee
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Weili He: Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie
Yixin Fang: Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie
Hongwei Wang: Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie
Charles Lee: CVRM Regulatory Affairs, AstraZeneca

A chapter in Real-World Evidence in Medical Product Development, 2023, pp 3-16 from Springer

Abstract: Abstract The organic and evolving nature of real-world Data (RWD) and real-world evidence (RWE) responding to the need of establishing RWE and the fit-for-purpose requirements for expanding applications of RWE to address payers, patients, physicians’ need along with supporting regulatory decisions is a defining characteristic of this arena. This chapter will introduce RWD and RWE definitions and discuss the need for the use of RWD in the various stages of drug development, given the increasing uptake of RWE across regulatory, industry, and academia globally. Great progresses have been made in the last few years in this field, which we will review and summarize. Further, we will provide our thoughts on the further opportunities to address continued challenges and future directions.

Keywords: Real-world data; Real-world evidence; FDA RWE framework; ICH E9(R1) addendum; Estimand (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_1

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DOI: 10.1007/978-3-031-26328-6_1

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