The real-world data challenges radar: a review on the challenges and risks regarding the use of real-world data
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Author (Corporation)
Publication date
2021
Typ of student thesis
Course of study
Collections
Type
01A - Journal article
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Editor (Corporation)
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Parent work
Digital Biomarkers
Special issue
DOI of the original publication
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Series
Series number
Volume
5
Issue / Number
2
Pages / Duration
148-157
Patent number
Publisher / Publishing institution
Karger
Place of publication / Event location
Basel
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Abstract
Background: The life science industry has a strong interest in real-world data (RWD), a term that is currently being used in many ways and with varying definitions depending on the source. In this review article, we provide a summary overview of the challenges and risks regarding the use of RWD and its translation into real-world evidence and provide a classification and visualization of RWD challenges by means of the RWD Challenges Radar.
Summary: Based on a systematic literature search, we identified 3 types of challenges – organizational, technological, and people-based – that must be addressed when deriving evidence from RWD to be used in drug approval and other applications. It further demonstrates that numerous different aspects, for example, related to the application field and the associated industry, must be considered. A key finding in our review is that the regulatory landscape must be carefully assessed before utilizing RWD.
Key Messages: Establishing awareness and insight into the challenges and risks regarding the use of RWD will be key to taking full advantage of the RWD potential. As a result of this review, an “RWD Challenges Radar” will support the establishment of awareness by providing a comprehensive overview of the relevant aspects to be considered when employing RWD.
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Subject (DDC)
330 - Wirtschaft
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ISBN
ISSN
2504-110X
Language
English
Created during FHNW affiliation
Yes
Strategic action fields FHNW
Publication status
Published
Review
Peer review of the complete publication
Open access category
Gold
License
Citation
GRIMBERG, Frank, Petra ASPRION, Bettina SCHNEIDER, Enkelejda MIHO, Lmar BABRAK und Ali HABBABEH, 2021. The real-world data challenges radar: a review on the challenges and risks regarding the use of real-world data. Digital Biomarkers. 2021. Bd. 5, Nr. 2, S. 148–157. DOI 10.1159/000516178. Verfügbar unter: https://doi.org/10.26041/fhnw-7033