Journal article
Are noninferiority studies ethically inferior?
American journal of health-system pharmacy, Vol.75(12), pp.911-914
06/15/2018
DOI: 10.2146/ajhp170437
PMID: 29880526
Abstract
Although many authors have addressed the ethics of placebo-controlled trials, few have addressed the ethics of noninferiority trials.1–3 The purpose of this commentary is to explore some of the ethical issues associated with noninferiority trials. We posit that there are several ethical problems inherent in the design of noninferiority studies. It is our contention that by their very design, noninferiority studies may not meet the assumption of clinical equipoise. We also argue that over time, noninferiority studies may result in a less-effective treatment becoming the standard of care. Prescribing this less-effective treatment would violate the principles of beneficence and nonmaleficence. Each of these points will be addressed as we unpack our arguments.
Details
- Title: Subtitle
- Are noninferiority studies ethically inferior?
- Creators
- Mark A. Graber - University of IowaJohn Ely - University of IowaBrett A. Faine - University of Iowa
- Resource Type
- Journal article
- Publication Details
- American journal of health-system pharmacy, Vol.75(12), pp.911-914
- Publisher
- Oxford Univ Press
- DOI
- 10.2146/ajhp170437
- PMID
- 29880526
- ISSN
- 1079-2082
- eISSN
- 1535-2900
- Number of pages
- 4
- Language
- English
- Date published
- 06/15/2018
- Academic Unit
- Emergency Medicine; Family and Community Medicine; Pharmacy Practice and Science
- Record Identifier
- 9984548263802771
Metrics
14 Record Views