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?.

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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

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Creado:	Thu, 06 Jun 2019, 01:23:54 CET by David Teira

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