Edwards, SJL;
(2013)
Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside.
AMERICAN JOURNAL OF BIOETHICS
, 13
(9)
3 - 14.
10.1080/15265161.2013.813597.
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Abstract
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.
| Type: | Article |
|---|---|
| Title: | Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1080/15265161.2013.813597 |
| Publisher version: | http://dx.doi.org/10.1080/15265161.2013.813597 |
| Additional information: | © Sarah J.L. Edwards 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. PubMed ID: 23952822 |
| Keywords: | research ethics, public health |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > UCL BEAMS UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences > Dept of Science and Technology Studies |
| URI: | https://discovery.ucl.ac.uk/id/eprint/1411125 |
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