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Digital Health Applications for Pharmacogenetic Clinical Trials

Digital health (DH) is the use of digital technologies and data analytics to understand health-related behaviors and enhance personalized clinical care. DH is increasingly being used in clinical trials, and an important field that could potentially benefit from incorporating DH into trial design is...

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Detalles Bibliográficos
Autores principales: Naik, Hetanshi, Palaniappan, Latha, Ashley, Euan A., Scott, Stuart A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7692850/
https://www.ncbi.nlm.nih.gov/pubmed/33114567
http://dx.doi.org/10.3390/genes11111261
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author Naik, Hetanshi
Palaniappan, Latha
Ashley, Euan A.
Scott, Stuart A.
author_facet Naik, Hetanshi
Palaniappan, Latha
Ashley, Euan A.
Scott, Stuart A.
author_sort Naik, Hetanshi
collection PubMed
description Digital health (DH) is the use of digital technologies and data analytics to understand health-related behaviors and enhance personalized clinical care. DH is increasingly being used in clinical trials, and an important field that could potentially benefit from incorporating DH into trial design is pharmacogenetics. Prospective pharmacogenetic trials typically compare a standard care arm to a pharmacogenetic-guided therapeutic arm. These trials often require large sample sizes, are challenging to recruit into, lack patient diversity, and can have complicated workflows to deliver therapeutic interventions to both investigators and patients. Importantly, the use of DH technologies could mitigate these challenges and improve pharmacogenetic trial design and operation. Some DH use cases include (1) automatic electronic health record-based patient screening and recruitment; (2) interactive websites for participant engagement; (3) home- and tele-health visits for patient convenience (e.g., samples for lab tests, physical exams, medication administration); (4) healthcare apps to collect patient-reported outcomes, adverse events and concomitant medications, and to deliver therapeutic information to patients; and (5) wearable devices to collect vital signs, electrocardiograms, sleep quality, and other discrete clinical variables. Given that pharmacogenetic trials are inherently challenging to conduct, future pharmacogenetic utility studies should consider implementing DH technologies and trial methodologies into their design and operation.
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spelling pubmed-76928502020-11-28 Digital Health Applications for Pharmacogenetic Clinical Trials Naik, Hetanshi Palaniappan, Latha Ashley, Euan A. Scott, Stuart A. Genes (Basel) Review Digital health (DH) is the use of digital technologies and data analytics to understand health-related behaviors and enhance personalized clinical care. DH is increasingly being used in clinical trials, and an important field that could potentially benefit from incorporating DH into trial design is pharmacogenetics. Prospective pharmacogenetic trials typically compare a standard care arm to a pharmacogenetic-guided therapeutic arm. These trials often require large sample sizes, are challenging to recruit into, lack patient diversity, and can have complicated workflows to deliver therapeutic interventions to both investigators and patients. Importantly, the use of DH technologies could mitigate these challenges and improve pharmacogenetic trial design and operation. Some DH use cases include (1) automatic electronic health record-based patient screening and recruitment; (2) interactive websites for participant engagement; (3) home- and tele-health visits for patient convenience (e.g., samples for lab tests, physical exams, medication administration); (4) healthcare apps to collect patient-reported outcomes, adverse events and concomitant medications, and to deliver therapeutic information to patients; and (5) wearable devices to collect vital signs, electrocardiograms, sleep quality, and other discrete clinical variables. Given that pharmacogenetic trials are inherently challenging to conduct, future pharmacogenetic utility studies should consider implementing DH technologies and trial methodologies into their design and operation. MDPI 2020-10-26 /pmc/articles/PMC7692850/ /pubmed/33114567 http://dx.doi.org/10.3390/genes11111261 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Naik, Hetanshi
Palaniappan, Latha
Ashley, Euan A.
Scott, Stuart A.
Digital Health Applications for Pharmacogenetic Clinical Trials
title Digital Health Applications for Pharmacogenetic Clinical Trials
title_full Digital Health Applications for Pharmacogenetic Clinical Trials
title_fullStr Digital Health Applications for Pharmacogenetic Clinical Trials
title_full_unstemmed Digital Health Applications for Pharmacogenetic Clinical Trials
title_short Digital Health Applications for Pharmacogenetic Clinical Trials
title_sort digital health applications for pharmacogenetic clinical trials
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7692850/
https://www.ncbi.nlm.nih.gov/pubmed/33114567
http://dx.doi.org/10.3390/genes11111261
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