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Conducting dermatology clinical trials during the COVID-19 pandemic
The clinical trials industry faces a number of challenges during the evolving coronavirus disease 2019 (COVID-19) pandemic, for example, site closures, mandatory self-isolation, travel restrictions, interruptions to delivery of investigational product, or staff or participants becoming infected with...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7832606/ https://www.ncbi.nlm.nih.gov/pubmed/33972036 http://dx.doi.org/10.1016/j.clindermatol.2020.12.019 |
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author | Sheriff, Tabrez Dickenson-Panas, Helen Murrell, Dédée F. |
author_facet | Sheriff, Tabrez Dickenson-Panas, Helen Murrell, Dédée F. |
author_sort | Sheriff, Tabrez |
collection | PubMed |
description | The clinical trials industry faces a number of challenges during the evolving coronavirus disease 2019 (COVID-19) pandemic, for example, site closures, mandatory self-isolation, travel restrictions, interruptions to delivery of investigational product, or staff or participants becoming infected with severe acute respiratory syndrome coronavirus 2. These challenges can pose difficulties in adhering to visit schedules, performing laboratory testing, conducting protocol-specified procedures, and administration of investigational product. As a result, clinical trial sites, contract research organizations, and sponsors have had to act swiftly to ensure that trial patients are safe and systems are in place for continuing trials. Protocols should also be amended to reflect changes and approved by an ethics board. The authors provide practical considerations and recommendations for dermatology clinical trial operations during the COVID-19 pandemic. |
format | Online Article Text |
id | pubmed-7832606 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-78326062021-01-26 Conducting dermatology clinical trials during the COVID-19 pandemic Sheriff, Tabrez Dickenson-Panas, Helen Murrell, Dédée F. Clin Dermatol Article The clinical trials industry faces a number of challenges during the evolving coronavirus disease 2019 (COVID-19) pandemic, for example, site closures, mandatory self-isolation, travel restrictions, interruptions to delivery of investigational product, or staff or participants becoming infected with severe acute respiratory syndrome coronavirus 2. These challenges can pose difficulties in adhering to visit schedules, performing laboratory testing, conducting protocol-specified procedures, and administration of investigational product. As a result, clinical trial sites, contract research organizations, and sponsors have had to act swiftly to ensure that trial patients are safe and systems are in place for continuing trials. Protocols should also be amended to reflect changes and approved by an ethics board. The authors provide practical considerations and recommendations for dermatology clinical trial operations during the COVID-19 pandemic. Elsevier Inc. 2021 2020-12-16 /pmc/articles/PMC7832606/ /pubmed/33972036 http://dx.doi.org/10.1016/j.clindermatol.2020.12.019 Text en © 2020 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Sheriff, Tabrez Dickenson-Panas, Helen Murrell, Dédée F. Conducting dermatology clinical trials during the COVID-19 pandemic |
title | Conducting dermatology clinical trials during the COVID-19 pandemic |
title_full | Conducting dermatology clinical trials during the COVID-19 pandemic |
title_fullStr | Conducting dermatology clinical trials during the COVID-19 pandemic |
title_full_unstemmed | Conducting dermatology clinical trials during the COVID-19 pandemic |
title_short | Conducting dermatology clinical trials during the COVID-19 pandemic |
title_sort | conducting dermatology clinical trials during the covid-19 pandemic |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7832606/ https://www.ncbi.nlm.nih.gov/pubmed/33972036 http://dx.doi.org/10.1016/j.clindermatol.2020.12.019 |
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