Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Sheriff, Tabrez, Dickenson-Panas, Helen, Murrell, Dédée F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Inc. 2021
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
_version_ 1783641874613927936
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
work_keys_str_mv AT sherifftabrez conductingdermatologyclinicaltrialsduringthecovid19pandemic
AT dickensonpanashelen conductingdermatologyclinicaltrialsduringthecovid19pandemic
AT murrelldedeef conductingdermatologyclinicaltrialsduringthecovid19pandemic