The ethics of non-inferiority trials: A consequentialist analysis

Research Ethics 9 (3):109-120 (2013)
  Copy   BIBTEX


Discussions about the merits and shortcomings of non-inferiority trials are becoming increasingly common in the medical community and among regulatory agencies. However, criticisms targeting the ethical standing of non-inferiority trials have often been mistargeted. In this article we review the ethical standing of trials of non-inferiority. In the first part of the article, we outline a consequentialist position according to which clinical trials are best conceived as epistemic tools aimed at fostering the proper ends of medicine. According to this view, clinical trials are means to ends, and thus their moral status depends both on how well they perform as means to reach desired ends and on which ends they are meant to achieve. Building upon this normative framework in the next two sections we analyze the specific ethical issues raised by non-inferiority trials. By making it clear that clinical trials are just epistemic tools – i.e. means to certain ends – it is possible not only to clarify the conceptual debate over a fundamental issue in clinical research, but also to identify which ethically relevant considerations ought to be addressed in setting up a non-inferiority trial



    Upload a copy of this work     Papers currently archived: 74,247

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

The Research Misconception.Maurie Markman - 2004 - International Journal of Applied Philosophy 18 (2):241-252.
Uncertainty and the Ethics of Clinical Trials.Sven Ove Hansson - 2006 - Theoretical Medicine and Bioethics 27 (2):149-167.
What Makes Placebo-Controlled Trials Unethical?Franklin G. Miller & Howard Brody - 2002 - American Journal of Bioethics 2 (2):3 – 9.
Monitoring in Clinical Trials: Benefit or Bias?Cecilia Nardini - 2013 - Theoretical Medicine and Bioethics 34 (4):259-274.
The Protection of Patients' Rights in Clinical Trials.Marek Czarkowski - 2006 - Science and Engineering Ethics 12 (1):131-138.
Bayesian Versus Frequentist Clinical Trials.David Teira - 2011 - In Gifford Fred (ed.), Philosophy of Medicine. Amsterdam: Elsevier. pp. 255-297.


Added to PP

39 (#296,499)

6 months
1 (#415,205)

Historical graph of downloads
How can I increase my downloads?