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Erschienen in: Wiener klinische Wochenschrift 15-16/2021

09.04.2021 | review article

Real-world evidence and product development: Opportunities, challenges and risk mitigation

verfasst von: Poobalan Naidoo, Célia Bouharati, Virendra Rambiritch, Nadina Jose, Sumanth Karamchand, Robert Chilton, Rory Leisegang

Erschienen in: Wiener klinische Wochenschrift | Ausgabe 15-16/2021

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Summary

Real-world evidence (RWE) is derived from real-world data (RWD) sources including electronic health records, claims data, registries (disease, product) and pragmatic clinical trials. The importance of RWE derived from RWD has been once again demonstrated during the coronavirus disease 2019 (COVID-19) pandemic, as it can improve patient care by complementing information obtained from traditional clinical trial programs. Additionally, RWE can generate insights into disease mechanisms, epidemiology, patient flows in and out of healthcare systems, and drivers and barriers to optimal clinical care in real-world settings. Identifying unmet medical needs is crucial as it often can inform which investigational new drugs enter clinical trial testing, and RWE studies from hospital settings have contributed substantial progress here. RWE can also optimize the design of clinical studies, inform benefit risk assessments and use networks of pragmatic studies to help with clinical trial feasibilities and eventual trial initiation. The challenges of RWD include data quality, reproducibility and accuracy which may affect validity. RWD and RWE must be fit for purpose and one must be cognizant of inherent biases.
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Metadaten
Titel
Real-world evidence and product development: Opportunities, challenges and risk mitigation
verfasst von
Poobalan Naidoo
Célia Bouharati
Virendra Rambiritch
Nadina Jose
Sumanth Karamchand
Robert Chilton
Rory Leisegang
Publikationsdatum
09.04.2021
Verlag
Springer Vienna
Erschienen in
Wiener klinische Wochenschrift / Ausgabe 15-16/2021
Print ISSN: 0043-5325
Elektronische ISSN: 1613-7671
DOI
https://doi.org/10.1007/s00508-021-01851-w