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dc.contributor.authorEyal, Nir
dc.contributor.authorLipsitch, Marc
dc.date.accessioned2018-06-22T19:40:45Z
dc.date.issued2017
dc.identifierQuick submit: 2018-04-10T14:59:26-0400
dc.identifier.citationEyal, Nir, and Marc Lipsitch. 2017. “Vaccine Testing for Emerging Infections: The Case for Individual Randomisation.” Journal of Medical Ethics 43 (9) (April 10): 625–631. doi:10.1136/medethics-2015-103220.en_US
dc.identifier.issn0306-6800en_US
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:37147309
dc.description.abstractDuring the 2014-2015 Ebola outbreak in Guinea, Liberia and Sierra Leone, many opposed the use of individually randomised controlled trials to test candidate Ebola vaccines. For a raging fatal disease, they explained, it is unethical to relegate some study participants to control arms. In Zika and future emerging infections, similar opposition may hinder urgent vaccine research, so it is best to address these questions now. This article lays out the ethical case for individually randomised control in testing vaccines against many emerging infections, including lethal infections in low-income countries, even when at no point in the trial do the controls receive the countermeasures being tested. When individual randomisation is feasible-and it often will be-it tends to save more lives than alternative designs would. And for emerging infections, individual randomisation also tends as such to improve care, access to the experimental vaccine and prospects for all participants relative to their opportunities absent the trial, and no less than alternative designs would. That obtains even under placebo control and without equipoise-requiring which would undermine individual randomisation and the alternative designs that opponents proffered. Our arguments expound four often-neglected factors: benefits to non-participants, benefits to participants once a trial is over including post-trial access to the study intervention, participants' prospects before randomisation to arms and the near-inevitable disparity between arms in any randomised controlled trial.en_US
dc.language.isoen_USen_US
dc.publisherBMJen_US
dc.relation.isversionofdoi:10.1136/medethics-2015-103220en_US
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC5577361/en_US
dash.licenseOAP
dc.subjectAllocation of Health Care Resourcesen_US
dc.subjectClinical trialsen_US
dc.subjectEpidemiologyen_US
dc.subjectEthicsen_US
dc.subjectResearch Ethicsen_US
dc.titleVaccine testing for emerging infections: the case for individual randomisationen_US
dc.typeJournal Articleen_US
dc.date.updated2018-04-10T18:59:28Z
dc.description.versionAccepted Manuscripten_US
dc.relation.journalJournal of Medical Ethicsen_US
dash.depositing.authorLipsitch, Marc
dc.date.available2017
dc.date.available2018-06-22T19:40:45Z
dc.identifier.doi10.1136/medethics-2015-103220*
dash.contributor.affiliatedEyal, Nir
dash.contributor.affiliatedLipsitch, Marc


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