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Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic

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 valid...

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Detalles Bibliográficos
Autores principales: Izmailova, Elena S., Ellis, Robert, Benko, Christopher
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7307062/
https://www.ncbi.nlm.nih.gov/pubmed/32526077
http://dx.doi.org/10.1111/cts.12834
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author Izmailova, Elena S.
Ellis, Robert
Benko, Christopher
author_facet Izmailova, Elena S.
Ellis, Robert
Benko, Christopher
author_sort Izmailova, Elena S.
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description 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.
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spelling pubmed-73070622020-06-22 Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic Izmailova, Elena S. Ellis, Robert Benko, Christopher Clin Transl Sci Perspectives 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. John Wiley and Sons Inc. 2020-07-08 2020-09 /pmc/articles/PMC7307062/ /pubmed/32526077 http://dx.doi.org/10.1111/cts.12834 Text en © 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Perspectives
Izmailova, Elena S.
Ellis, Robert
Benko, Christopher
Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic
title Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic
title_full Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic
title_fullStr Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic
title_full_unstemmed Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic
title_short Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic
title_sort remote monitoring in clinical trials during the covid‐19 pandemic
topic Perspectives
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7307062/
https://www.ncbi.nlm.nih.gov/pubmed/32526077
http://dx.doi.org/10.1111/cts.12834
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