Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development
Regulatory acceptance of Digital Health Technology (DHT) -derived endpoints can be a long, multifaceted and costly process. Success relies on establishing a global strategy as part of the development program including health authority consultations to ensure alignment with regulatory requirements. I...
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| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-03-01
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| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-025-01513-5 |
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| _version_ | 1850028098942140416 |
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| author | Gül Erdemli Tina Murphy Sarah Walinsky |
| author_facet | Gül Erdemli Tina Murphy Sarah Walinsky |
| author_sort | Gül Erdemli |
| collection | DOAJ |
| description | Regulatory acceptance of Digital Health Technology (DHT) -derived endpoints can be a long, multifaceted and costly process. Success relies on establishing a global strategy as part of the development program including health authority consultations to ensure alignment with regulatory requirements. In this manuscript, the authors provide stepwise guidance for successful implementation of DHT-derived endpoints in clinical trials for drug development. |
| format | Article |
| id | doaj-art-bcbea46f41774657b1c092f9fa11c060 |
| institution | DOAJ |
| issn | 2398-6352 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Digital Medicine |
| spelling | doaj-art-bcbea46f41774657b1c092f9fa11c0602025-08-20T02:59:56ZengNature Portfolionpj Digital Medicine2398-63522025-03-01811810.1038/s41746-025-01513-5Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug developmentGül Erdemli0Tina Murphy1Sarah Walinsky2Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals CorporationNovartis Pharmaceuticals CorporationRegulatory acceptance of Digital Health Technology (DHT) -derived endpoints can be a long, multifaceted and costly process. Success relies on establishing a global strategy as part of the development program including health authority consultations to ensure alignment with regulatory requirements. In this manuscript, the authors provide stepwise guidance for successful implementation of DHT-derived endpoints in clinical trials for drug development.https://doi.org/10.1038/s41746-025-01513-5 |
| spellingShingle | Gül Erdemli Tina Murphy Sarah Walinsky Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development npj Digital Medicine |
| title | Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development |
| title_full | Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development |
| title_fullStr | Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development |
| title_full_unstemmed | Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development |
| title_short | Regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development |
| title_sort | regulatory considerations for successful implementation of digital endpoints in clinical trials for drug development |
| url | https://doi.org/10.1038/s41746-025-01513-5 |
| work_keys_str_mv | AT gulerdemli regulatoryconsiderationsforsuccessfulimplementationofdigitalendpointsinclinicaltrialsfordrugdevelopment AT tinamurphy regulatoryconsiderationsforsuccessfulimplementationofdigitalendpointsinclinicaltrialsfordrugdevelopment AT sarahwalinsky regulatoryconsiderationsforsuccessfulimplementationofdigitalendpointsinclinicaltrialsfordrugdevelopment |