Andreoletti, Mattia and Teira, David (2019) Rules versus Standards: What Are the Costs of Epistemic Norms in Drug Regulation? Science, Technology, & Human Values, 44 (6). pp. 1093-1115. ISSN 0162-2439
|
Text
AndreolettiTeira.pdf - Accepted Version Available under License Creative Commons Attribution No Derivatives. Download (178kB) | Preview |
Abstract
Over the last decade, philosophers of science have extensively criticized the epistemic superiority ofRandomized 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.
| Export/Citation: | EndNote | BibTeX | Dublin Core | ASCII/Text Citation (Chicago) | HTML Citation | OpenURL |
| Social Networking: |
| Item Type: | Published Article or Volume | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Creators: |
|
|||||||||
| Keywords: | Clinical trials EBM+ regulation | |||||||||
| Subjects: | Specific Sciences > Medicine > Clinical Trials General Issues > Experimentation Specific Sciences > Medicine General Issues > Science and Policy |
|||||||||
| Depositing User: | Prof. David Teira | |||||||||
| Date Deposited: | 22 Sep 2020 19:04 | |||||||||
| Last Modified: | 22 Sep 2020 19:04 | |||||||||
| Item ID: | 18131 | |||||||||
| Journal or Publication Title: | Science, Technology, & Human Values | |||||||||
| Official URL: | http://doi.org/10.1177/0162243919828070 | |||||||||
| DOI or Unique Handle: | 10.1177/0162243919828070 | |||||||||
| Subjects: | Specific Sciences > Medicine > Clinical Trials General Issues > Experimentation Specific Sciences > Medicine General Issues > Science and Policy |
|||||||||
| Date: | 2019 | |||||||||
| Page Range: | pp. 1093-1115 | |||||||||
| Volume: | 44 | |||||||||
| Number: | 6 | |||||||||
| ISSN: | 0162-2439 | |||||||||
| URI: | https://philsci-archive.pitt.edu/id/eprint/18131 |
Monthly Views for the past 3 years
Monthly Downloads for the past 3 years
Plum Analytics
Altmetric.com
Actions (login required)
 |
View Item |
![[feed]](http://philsci-archive.pitt.edu/style/images/feed-icon-32x32.png){kind=icon}