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Clinical trials in the pandemic age: What is fit for purpose?

It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for managing the pandemic, public health and clinical...

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Detalles Bibliográficos
Autores principales: Hartman, Dan, Heaton, Penny, Cammack, Nick, Hudson, Ian, Dolley, Shawn, Netsi, Elena, Norman, Thea, Mundel, Trevor
Formato: Online Artículo Texto
Lenguaje:English
Publicado: F1000 Research Limited 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7324688/
https://www.ncbi.nlm.nih.gov/pubmed/32656501
http://dx.doi.org/10.12688/gatesopenres.13146.1
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author Hartman, Dan
Heaton, Penny
Cammack, Nick
Hudson, Ian
Dolley, Shawn
Netsi, Elena
Norman, Thea
Mundel, Trevor
author_facet Hartman, Dan
Heaton, Penny
Cammack, Nick
Hudson, Ian
Dolley, Shawn
Netsi, Elena
Norman, Thea
Mundel, Trevor
author_sort Hartman, Dan
collection PubMed
description It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for managing the pandemic, public health and clinical capacity, travel and migration, and availability of tests and infrastructure. These factors lead to spikes and troughs in patient count by location, disrupting the ability to predict when or if a trial will reach recruitment goals. The focus must also be on understanding how to provide equitable access to these interventions ensuring that interventions reach those who need them the most, be it patients in low resource settings or vulnerable groups.  We introduce a website to be used by The Bill & Melinda Gates Foundation, Wellcome Trust, and other funders of the COVID Therapeutics Accelerator that accept proposals for future clinical research. The portal enables evaluations of clinical study applications that focus on study qualities most likely to lead to informative outcomes and completed studies.
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spelling pubmed-73246882020-07-09 Clinical trials in the pandemic age: What is fit for purpose? Hartman, Dan Heaton, Penny Cammack, Nick Hudson, Ian Dolley, Shawn Netsi, Elena Norman, Thea Mundel, Trevor Gates Open Res Open Letter It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for managing the pandemic, public health and clinical capacity, travel and migration, and availability of tests and infrastructure. These factors lead to spikes and troughs in patient count by location, disrupting the ability to predict when or if a trial will reach recruitment goals. The focus must also be on understanding how to provide equitable access to these interventions ensuring that interventions reach those who need them the most, be it patients in low resource settings or vulnerable groups.  We introduce a website to be used by The Bill & Melinda Gates Foundation, Wellcome Trust, and other funders of the COVID Therapeutics Accelerator that accept proposals for future clinical research. The portal enables evaluations of clinical study applications that focus on study qualities most likely to lead to informative outcomes and completed studies. F1000 Research Limited 2020-06-09 /pmc/articles/PMC7324688/ /pubmed/32656501 http://dx.doi.org/10.12688/gatesopenres.13146.1 Text en Copyright: © 2020 Hartman D et al. http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Open Letter
Hartman, Dan
Heaton, Penny
Cammack, Nick
Hudson, Ian
Dolley, Shawn
Netsi, Elena
Norman, Thea
Mundel, Trevor
Clinical trials in the pandemic age: What is fit for purpose?
title Clinical trials in the pandemic age: What is fit for purpose?
title_full Clinical trials in the pandemic age: What is fit for purpose?
title_fullStr Clinical trials in the pandemic age: What is fit for purpose?
title_full_unstemmed Clinical trials in the pandemic age: What is fit for purpose?
title_short Clinical trials in the pandemic age: What is fit for purpose?
title_sort clinical trials in the pandemic age: what is fit for purpose?
topic Open Letter
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7324688/
https://www.ncbi.nlm.nih.gov/pubmed/32656501
http://dx.doi.org/10.12688/gatesopenres.13146.1
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