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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| 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
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| Series: | Current Directions in Biomedical Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/cdbme-2024-2104 |
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