The Trade-off between Impartiality and Freedom in the 21st Century Cures Act
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 Congr...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
University Library System, University of Pittsburgh
2021-05-01
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| Series: | Philosophy of Medicine |
| Subjects: | |
| Online Access: | https://philmed.pitt.edu/philmed/article/view/24 |
| _version_ | 1811307372504678400 |
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| author | David Fraile Navarro Niccolò Tempini David Teira |
| author_facet | David Fraile Navarro Niccolò Tempini David Teira |
| author_sort | David Fraile Navarro |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T09:03:14Z |
| format | Article |
| id | doaj.art-5dbb23504c844386b58b2f2143b4c7ab |
| institution | Directory Open Access Journal |
| issn | 2692-3963 |
| language | English |
| last_indexed | 2024-04-13T09:03:14Z |
| publishDate | 2021-05-01 |
| publisher | University Library System, University of Pittsburgh |
| record_format | Article |
| series | Philosophy of Medicine |
| spelling | doaj.art-5dbb23504c844386b58b2f2143b4c7ab2022-12-22T02:53:04ZengUniversity Library System, University of PittsburghPhilosophy of Medicine2692-39632021-05-012110.5195/pom.2021.2424The Trade-off between Impartiality and Freedom in the 21st Century Cures ActDavid Fraile Navarro0Niccolò Tempini1David Teira2Australian Institute of Health Innovation, Macquarie University, Sydney, AustraliaDepartment of Sociology, Philosophy and Anthropology, Egenis & Institute for Data Science and Artificial Intelligence University of Exeter, Exeter, UK | Alan Turing Institute, London, UK.Dpto. de Lógica, Historia y Filosofía de la Ciencia, Universidad Nacional de Educación a Distancia, Madrid, SpainRandomized 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.https://philmed.pitt.edu/philmed/article/view/24pragmatic trialspaternalismfdablinding |
| spellingShingle | David Fraile Navarro Niccolò Tempini David Teira The Trade-off between Impartiality and Freedom in the 21st Century Cures Act Philosophy of Medicine pragmatic trials paternalism fda blinding |
| title | The Trade-off between Impartiality and Freedom in the 21st Century Cures Act |
| title_full | The Trade-off between Impartiality and Freedom in the 21st Century Cures Act |
| title_fullStr | The Trade-off between Impartiality and Freedom in the 21st Century Cures Act |
| title_full_unstemmed | The Trade-off between Impartiality and Freedom in the 21st Century Cures Act |
| title_short | The Trade-off between Impartiality and Freedom in the 21st Century Cures Act |
| title_sort | trade off between impartiality and freedom in the 21st century cures act |
| topic | pragmatic trials paternalism fda blinding |
| url | https://philmed.pitt.edu/philmed/article/view/24 |
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