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Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside

Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiv...

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Detalles Bibliográficos
Autor principal: Edwards, Sarah J. L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis Group 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4151792/
https://www.ncbi.nlm.nih.gov/pubmed/23952822
http://dx.doi.org/10.1080/15265161.2013.813597
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author Edwards, Sarah J. L.
author_facet Edwards, Sarah J. L.
author_sort Edwards, Sarah J. L.
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description Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiveness. To inform current policy, I reexamine the philosophical rationale for restricting new medicines to clinical trials, at any stage and for any population of patients (which resides in the precautionary principle), to show that its objective to protect public health, now or in the future, could soon be defeated in a pandemic. Providing wider therapeutic access and coordinating observations and natural experiments, including service delivery by cluster (wedged cluster trials), may provide such a balance. However, there are important questions of fairness to resolve before any such research can proceed.
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spelling pubmed-41517922014-09-08 Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside Edwards, Sarah J. L. Am J Bioeth Target Article Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiveness. To inform current policy, I reexamine the philosophical rationale for restricting new medicines to clinical trials, at any stage and for any population of patients (which resides in the precautionary principle), to show that its objective to protect public health, now or in the future, could soon be defeated in a pandemic. Providing wider therapeutic access and coordinating observations and natural experiments, including service delivery by cluster (wedged cluster trials), may provide such a balance. However, there are important questions of fairness to resolve before any such research can proceed. Taylor & Francis Group 2013-09-01 2013-08-16 /pmc/articles/PMC4151792/ /pubmed/23952822 http://dx.doi.org/10.1080/15265161.2013.813597 Text en © Sarah J.L. Edwards http://creativecommons.org/licenses/by/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License http://creativecommons.org/licenses/by/3.0/, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.
spellingShingle Target Article
Edwards, Sarah J. L.
Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside
title Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside
title_full Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside
title_fullStr Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside
title_full_unstemmed Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside
title_short Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside
title_sort ethics of clinical science in a public health emergency: drug discovery at the bedside
topic Target Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4151792/
https://www.ncbi.nlm.nih.gov/pubmed/23952822
http://dx.doi.org/10.1080/15265161.2013.813597
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