The real-world data challenges radar: a review on the challenges and risks regarding the use of real-world data
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Autor:in (Körperschaft)
Publikationsdatum
2021
Typ der Arbeit
Studiengang
Typ
01A - Beitrag in wissenschaftlicher Zeitschrift
Herausgeber:innen
Herausgeber:in (Körperschaft)
Betreuer:in
Übergeordnetes Werk
Digital Biomarkers
Themenheft
DOI der Originalpublikation
Link
Reihe / Serie
Reihennummer
Jahrgang / Band
5
Ausgabe / Nummer
2
Seiten / Dauer
148-157
Patentnummer
Verlag / Herausgebende Institution
Karger
Verlagsort / Veranstaltungsort
Basel
Auflage
Version
Programmiersprache
Abtretungsempfänger:in
Praxispartner:in/Auftraggeber:in
Zusammenfassung
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.
Schlagwörter
Fachgebiet (DDC)
330 - Wirtschaft
Veranstaltung
Startdatum der Ausstellung
Enddatum der Ausstellung
Startdatum der Konferenz
Enddatum der Konferenz
Datum der letzten Prüfung
ISBN
ISSN
2504-110X
Sprache
Englisch
Während FHNW Zugehörigkeit erstellt
Ja
Publikationsstatus
Veröffentlicht
Begutachtung
Peer-Review der ganzen Publikation
Open Access-Status
Gold
Lizenz
Zitation
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