Learning from patient and site perspectives to develop better digital health trials: Recommendations from the Clinical Trials Transformation Initiative.
| Autor: | Geoghegan C; Patient and Partners LLC, Madison, CT, USA., Nido V; Genentech, Inc., South San Francisco, CA, USA., Bemden AB; Arthritis Foundation, Atlanta, GA, USA., Hallinan Z; Clinical Trials Transformation Initiative, Durham, NC, USA., Jordan L; Target Health Inc., New York, NY, USA., Kehoe LS; Clinical Trials Transformation Initiative, Durham, NC, USA., Morin SL; Office of Health and Constituent Affairs, US Food and Drug Administration, Silver Spring, MD, USA., Niskar A; Patient Voice Representative, Atlanta, GA, USA., Okubagzi PG; MedStar Health, Columbia, MD, USA., Wood WA; University of North Carolina, Chapel Hill, NC, USA. |
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| Jazyk: | angličtina |
| Zdroj: | Contemporary clinical trials communications [Contemp Clin Trials Commun] 2020 Aug 13; Vol. 19, pp. 100636. Date of Electronic Publication: 2020 Aug 13 (Print Publication: 2020). |
| DOI: | 10.1016/j.conctc.2020.100636 |
| Abstrakt: | In order to harness the potential of digital health technologies to enhance the quality of clinical research, it is critical to first understand how to engage patients and research sites when planning and conducting digital health trials. To pave the way for the more effective use of digital health technologies in trials, the Clinical Trials Transformation Initiative has developed the first comprehensive, evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials. While directed primarily at sponsors, these recommendations are expected to be valuable for all stakeholders including investigators. Competing Interests: The authors have no conflicting interests to disclose. (© 2020 Published by Elsevier Inc.) |
| Databáze: | MEDLINE |
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