Remote Monitoring in Clinical Trials During the COVID-19 Pandemic.
Betacoronavirus
/ pathogenicity
COVID-19
Clinical Trials as Topic
/ methods
Coronavirus Infections
/ epidemiology
Data Collection
/ instrumentation
Humans
Infection Control
/ standards
Monitoring, Physiologic
/ instrumentation
Pandemics
/ prevention & control
Patient Participation
Patient Selection
Pneumonia, Viral
/ epidemiology
Remote Sensing Technology
Research Design
SARS-CoV-2
Telemedicine
/ instrumentation
Journal
Clinical and translational science
ISSN: 1752-8062
Titre abrégé: Clin Transl Sci
Pays: United States
ID NLM: 101474067
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
07
05
2020
accepted:
03
06
2020
pubmed:
12
6
2020
medline:
23
9
2020
entrez:
12
6
2020
Statut:
ppublish
Résumé
The coronavirus disease 2019 (COVID-19) pandemic has rapidly challenged the pharmaceutical industry to implement remote clinical trials. The industry's lack of extensive experience with remote measurements initiates multiple questions about how to select candidates for remote collection, their validity, and regulatory implications of moving certain assessments to a remote mode. We propose a decision tree for migration of clinic to remote assessments and highlight activities required to ensure that these measurements are valid, safe, and usable.
Identifiants
pubmed: 32526077
doi: 10.1111/cts.12834
pmc: PMC7307062
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
838-841Informations de copyright
© 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.
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