Clinical Equipoise and the Incoherence of Research Ethics∗

∗This article not subject to United States copyright law. The opinions expressed are the views of the authors and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the U.S. Department of Health and Human Services.

Abstract

The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized to an intervention known to be inferior to standard treatment. Second, the claim that RCTs preserve the therapeutic obligation of physicians misrepresents the patient-centered orientation of medical care. Third, the appeal to clinical equipoise as a basic principle of risk-benefit assessment for RCTs is incoherent. Finally, the difficulties with clinical equipoise cannot be resolved by viewing it as a presumptive principle subject to exceptions. In the final sections of the article, we elaborate on the non-exploitation framework for the ethics clinical research and indicate issues that warrant further inquiry.

Keywords:

• clinical equipoise
• exploitation
• randomized controlled trials
• risk-benefit assessment

Notes

∗This article not subject to United States copyright law. The opinions expressed are the views of the authors and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the U.S. Department of Health and Human Services.

1. This odd depiction of the way that the attending physician selects treatment for the patient is also foreign to the conception of Charles Fried, who is credited with having first introduced the concept of ‘equipoise’ into research ethics in 1974 (Fried, 1974). Fried laid great emphasis on “rights in personal care,” which assumed that the physician made an individualized judgment about what treatment would be best for each patient. While Benjamin Freedman, like Fried, grounded his view of equipoise in what we call the “similarity position,” he appears to have neglected Fried's earlier admonitions about what the ethics of therapeutic medicine require of the physician (Freedman, 1987).