How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints
Introduction: Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is limited. Methods: From November 2020 through March 2021, th...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Karger Publishers
2023-06-01
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| Series: | Digital Biomarkers |
| Subjects: | |
| Online Access: | https://beta.karger.com/Article/FullText/529878 |