A normalized quality of life approach for regulatory approval of medical devices

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decisionmaking, regulatory and economic analyses and health policy. The hetero...

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Bibliographic Details
Main Authors: Leuchter Matthias, Philipp Mark, Siewert Stefan, Schafmayer Clemens, Schmitz Klaus-Peter, Kaule Sebastian
Format: Article
Language:English
Published: De Gruyter 2024-12-01
Series:Current Directions in Biomedical Engineering
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Online Access:https://doi.org/10.1515/cdbme-2024-2104
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