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The Trade-off between Impartiality and Freedom in the 21st Century Cures Act

Fraile Navarro, David and Tempini, Niccolo and Teira, David (2021) The Trade-off between Impartiality and Freedom in the 21st Century Cures Act. Philosophy of Medicine, 2 (1). pp. 1-17. ISSN 2692-3963

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Randomized controlled trials test new drugs using various debiasing devices to prevent participants from manipulating the trials. But participants often dislike controls, arguing that they impose a paternalist constraint on their legitimate preferences. The 21st Century Cures Act, passed by US Congress in 2016, encourages the Food and Drug Administration to use alternative testing methods, incorporating participants’ preferences, for regulatory purposes. We discuss, from a historical perspective, the trade-off between trial impartiality and participants’ freedom. We argue that the only way out is considering which methods improve upon the performance of conventional trials in keeping dangerous or inefficacious compounds out of pharmaceutical markets.

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Item Type: Published Article or Volume
Fraile Navarro,
Teira, Daviddteira@fsof.uned.es0000-0002-4551-2371
Keywords: Pragmatic trials Paternalism FDA Blinding
Subjects: Specific Sciences > Medicine > Biomedical Ethics
Depositing User: Professor Alex Broadbent
Date Deposited: 18 Jun 2022 14:47
Last Modified: 08 Jul 2022 14:51
Item ID: 20758
Journal or Publication Title: Philosophy of Medicine
Publisher: University Library System, University of Pittsburgh
Official URL:
DOI or Unique Handle: 10.5195/pom.2021.24
Subjects: Specific Sciences > Medicine > Biomedical Ethics
Date: 28 May 2021
Page Range: pp. 1-17
Volume: 2
Number: 1
ISSN: 2692-3963

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