Assessment of Fit-for-Use Real-World Data Sources and Applications

Weili He (), Zuoyi Zhang and Sai Dharmarajan
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Weili He: Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie
Zuoyi Zhang: Medical Affairs and Health Technology Assessment Statistics, Data and Statistical Sciences, AbbVie
Sai Dharmarajan: FDA CDER

A chapter in Real-World Evidence in Medical Product Development, 2023, pp 45-61 from Springer

Abstract: Abstract The use of real-world data (RWD) and evidence (RWE) in clinical development to support regulatory decisions has gained increasing momentum in recent years. With the release of US Food and Drug Administration (FDA) draft guidance on Assessing Electronic Health Records (EHR) and Medical Claims Data and Registries to support regulatory decisions-making for drug and biological products in September and November 2021, respectively, and several white papers from Duke Margolis in 2018 and 2019, much inroad has been made in the understanding of how fit-for-use RWD sources could be assessed. Further, the ASA Biopharmaceutical Section-(BIOP)sponsored RWE Scientific Working Group (SWG) developed a semi-quantitative approach in the assessment of fit-for-use RWD sources. In this chapter, we will first review the guiding principles as outlined in the various literature. We will then provide a review and summary of RWD sources and type of settings where RWD may be used more effectively and fit-for-use for regulatory purposes. Using the semi-quantitative approach proposed by the RWE SWG, we will illustrate the actual assessment applications via an example from an RWD source.

Keywords: Real-world data; Real-world evidence; Fit-for-use; Randomized controlled trials; DUPLICATE; ConcertAI; Estimand; Data relevancy; Data reliability (search for similar items in EconPapers)
Date: 2023
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DOI: 10.1007/978-3-031-26328-6_4

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