Landscape of informed consent practices and challenges in point‐of‐care clinical trials
Abstract Point‐of‐care trials, an approach to trial design that assesses medical product effectiveness while fully integrating research and care, represent a promising opportunity to generate practically relevant evidence efficiently for priority disease areas. However, this approach presents unique...
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| Format: | Article |
| Language: | English |
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Wiley
2025-07-01
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| Series: | Learning Health Systems |
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| Online Access: | https://doi.org/10.1002/lrh2.10467 |
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| author | Caleigh Propes Trevan Locke Rachele Hendricks‐Sturrup |
| author_facet | Caleigh Propes Trevan Locke Rachele Hendricks‐Sturrup |
| author_sort | Caleigh Propes |
| collection | DOAJ |
| description | Abstract Point‐of‐care trials, an approach to trial design that assesses medical product effectiveness while fully integrating research and care, represent a promising opportunity to generate practically relevant evidence efficiently for priority disease areas. However, this approach presents unique considerations for appropriate and ethical informed consent. As point‐of‐care trials evolve, it will be important to examine informed consent through the lens of their supporting technology, of the clinicians who are responsible for administering it, and of their broader regulatory environment. Steps should be taken to establish ethical standards for point‐of‐care trials that reflect and serve the best interests of patients while reducing administrative burden and complexity. Our commentary describes, overall and through the use of real‐world examples, how this work is vital to ensuring a modern clinical trial enterprise that is patient‐centered and equips patients to make fully informed decisions about their health care. |
| format | Article |
| id | doaj-art-8bbab37d8b8e4544974ecdb5b86f642f |
| institution | Kabale University |
| issn | 2379-6146 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Learning Health Systems |
| spelling | doaj-art-8bbab37d8b8e4544974ecdb5b86f642f2025-08-20T03:50:50ZengWileyLearning Health Systems2379-61462025-07-0193n/an/a10.1002/lrh2.10467Landscape of informed consent practices and challenges in point‐of‐care clinical trialsCaleigh Propes0Trevan Locke1Rachele Hendricks‐Sturrup2Department of Health Policy and Management Johns Hopkins Bloomberg School of Public Health and the Berman Institute of Bioethics Baltimore Maryland USADuke‐Robert J. Margolis, MD, Institute for Health Policy, Duke University Washington DC USADuke‐Robert J. Margolis, MD, Institute for Health Policy, Duke University Washington DC USAAbstract Point‐of‐care trials, an approach to trial design that assesses medical product effectiveness while fully integrating research and care, represent a promising opportunity to generate practically relevant evidence efficiently for priority disease areas. However, this approach presents unique considerations for appropriate and ethical informed consent. As point‐of‐care trials evolve, it will be important to examine informed consent through the lens of their supporting technology, of the clinicians who are responsible for administering it, and of their broader regulatory environment. Steps should be taken to establish ethical standards for point‐of‐care trials that reflect and serve the best interests of patients while reducing administrative burden and complexity. Our commentary describes, overall and through the use of real‐world examples, how this work is vital to ensuring a modern clinical trial enterprise that is patient‐centered and equips patients to make fully informed decisions about their health care.https://doi.org/10.1002/lrh2.10467informed consentpoint‐of‐care trialspragmatic trialsreal‐world datareal‐world evidence |
| spellingShingle | Caleigh Propes Trevan Locke Rachele Hendricks‐Sturrup Landscape of informed consent practices and challenges in point‐of‐care clinical trials Learning Health Systems informed consent point‐of‐care trials pragmatic trials real‐world data real‐world evidence |
| title | Landscape of informed consent practices and challenges in point‐of‐care clinical trials |
| title_full | Landscape of informed consent practices and challenges in point‐of‐care clinical trials |
| title_fullStr | Landscape of informed consent practices and challenges in point‐of‐care clinical trials |
| title_full_unstemmed | Landscape of informed consent practices and challenges in point‐of‐care clinical trials |
| title_short | Landscape of informed consent practices and challenges in point‐of‐care clinical trials |
| title_sort | landscape of informed consent practices and challenges in point of care clinical trials |
| topic | informed consent point‐of‐care trials pragmatic trials real‐world data real‐world evidence |
| url | https://doi.org/10.1002/lrh2.10467 |
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