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Rules versus standards: what are the costs of epistemic norms in drug regulation?

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dc.contributor.authorAndreoletti, Mattia
dc.contributor.authorTeira Serrano, David
dc.date.accessioned2024-05-21T12:53:15Z
dc.date.available2024-05-21T12:53:15Z
dc.date.issued2019-01-01
dc.description.abstractOver the last decade, philosophers of science have extensively criticized the epistemic superiority of Randomized Controlled Trials (RCTs) for testing safety and effectiveness of new drugs, defending instead various forms of evidential pluralism. We argue that scientific methods in regulatory decision making cannot be assessed in epistemic terms only: there are costs involved. Drawing on the legal distinction between rules and standards, we show that drug regulation based on evidential pluralism has much higher costs than our current RCT-based system. We analyze these costs and advocate for evaluating any scheme for drug regulatory tests in terms of concrete empirical benchmarks, like the error rates of regulatory decisions.en
dc.description.versionversión final
dc.identifier.doihttps://doi.org/10.1177/0162243919828070
dc.identifier.urihttps://hdl.handle.net/20.500.14468/19423
dc.journal.titleScience, Technology and Human Values
dc.relation.centerFacultades y escuelas::Facultad de Filosofía
dc.relation.departmentLógica, Historia y Filosofía de la Ciencia
dc.rightsAtribución-NoComercial-SinDerivadas 4.0 Internacional
dc.rightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0
dc.subject.keywordsclinical trials
dc.subject.keywordsrules
dc.subject.keywordsstandards
dc.titleRules versus standards: what are the costs of epistemic norms in drug regulation?es
dc.typeartículoes
dc.typejournal articleen
dspace.entity.typePublication
person.familyNameTeira Serrano
person.givenNameDavid
person.identifier.orcid0000-0002-4551-2371
relation.isAuthorOfPublicationad2bda75-c33c-48e1-aad8-c7eb3cfc04cb
relation.isAuthorOfPublication.latestForDiscoveryad2bda75-c33c-48e1-aad8-c7eb3cfc04cb
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