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

Andreoletti, Mattia y Teira, David . (2019) Rules versus standards: what are the costs of epistemic norms in drug regulation?.

Ficheros (Some files may be inaccessible until you login with your e-spacio credentials)
Nombre Descripción Tipo MIME Size
AndreolettiTeira.pdf AndreolettiTeira.pdf application/pdf 174.49KB

Título Rules versus standards: what are the costs of epistemic norms in drug regulation?
Autor(es) Andreoletti, Mattia
Teira, David
Materia(s) Filosofía
Abstract Over 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.
Palabras clave clinical trials
rules
standards
Fecha 2019-01-01
Formato application/pdf
Identificador bibliuned:501116
DOI - identifier https://doi.org/10.1177/0162243919828070
Nombre de la revista Science, Technology and Human Values
Versión de la publicación acceptedVersion
Tipo de recurso Article
Derechos de acceso y licencia http://creativecommons.org/licenses/by-nc-nd/4.0
Tipo de acceso Acceso abierto

Tipo de documento: Artículo de revista
Collection: Departamento Lógica, Historia, Filosofía de la Ciencia (UNED). Artículos
 
Versiones
Versión Tipo de filtro
Contador de citas: Google Scholar Search Google Scholar
Estadísticas de acceso: 86 Visitas, 12 Descargas  -  Estadísticas en detalle
Creado: Thu, 06 Jun 2019, 01:23:54 CET by David Teira