Clinical equipoise: Why still the gold standard for randomized clinical trials?

Author:

Asonganyi Folefac Charlemagne12,Desmond Hugh134ORCID

Affiliation:

1. Centre for Biomedical Ethics and Law, KU Leuven, Leuven, Belgium

2. Experimental Clinical Oncology - Department of Oncology. Aarhus University Hospital, Aarhus, Denmark

3. Institute for the History and Philosophy of Science and Technology, CNRS/Paris I-Sorbonne

4. Department of Philosophy, University of Antwerp, Antwerp, Belgium

Abstract

The principle of clinical equipoise has been variously characterized by ethicists and clinicians as fundamentally flawed, a myth, and even a moral balm. Yet, the principle continues to be treated as the de facto gold standard for conducting randomized control trials in an ethical manner. Why do we hold on to clinical equipoise, despite its shortcomings being widely known and well-advertised? This paper reviews the most important arguments criticizing clinical equipoise as well as what the most prominent proposed alternatives are. In the process, it evaluates the justification for continuing to use clinical equipoise as the gold standard for randomized control trials.

Funder

Horizon 2020 Framework Programme

Publisher

SAGE Publications

Subject

Philosophy,Issues, ethics and legal aspects,Medicine (miscellaneous)

Reference71 articles.

1. Nuremberg Code. The Nuremberg Code, https://history.nih.gov/research/downloads/nuremberg.pdf (1947, accessed 28 January 2019).

2. Equipoise and the Ethics of Clinical Research

3. WMA (The World Medical Association). Declaration of Helsinki: ethical principles for medical research involving human subjects, https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (2013, accessed 28 January 2019).

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