Abstract

Digital technologies have transformed almost every aspect of our lives over the past decade including the way we communicate, shop, and read. Digital health technologies, despite their reputation for over-promising and under-delivering, can potentially offer the solutions needed to transform clinical trials, if backed by sufficient investment and regulatory support. However, this cannot be accomplished by replicating the current research processes and just transforming them from paper to digital form. Rather, a complete re-thinking and re-engineering of the clinical trial experience around the participant rather than the research site is needed. While some trials could be entirely digital in a virtual environment, many will need a hybrid of virtual and clinical site-based activities.

Details

Title
Digital clinical trials: creating a vision for the future
Author
Steinhubl, Steven R 1   VIAFID ORCID Logo  ; Wolff-Hughes, Dana L 2   VIAFID ORCID Logo  ; Nilsen, Wendy 3 ; Iturriaga, Erin 4 ; Califf, Robert M 5 

1  Scripps Research Translational Institute & Wave Research Center, LaJolla, USA 
2  Office of Behavioral and Social Sciences Research, National Institutes of Health, Bethesda, USA 
3  Computer and Information Science and Engineering, National Science Foundation, Alexandria, USA 
4  National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, USA (GRID:grid.279885.9) (ISNI:0000 0001 2293 4638) 
5  Duke University School of Medicine, Verily Life Sciences, Alphabet Inc, South San Francisco, California, USA and Duke Forge, Durham, USA (GRID:grid.26009.3d) (ISNI:0000 0004 1936 7961) 
Publication year
2019
Publication date
Dec 2019
Publisher
Nature Publishing Group
e-ISSN
23986352
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1038/s41746-019-0203-0
ProQuest document ID
2525627355
Copyright
© The Author(s) 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.