Jonathan Kimmelman | Clinical Trials: Journal of the Society for Clinical Trials | October 2012 | Vol. 9 No. 5, 630-631
The principle of clinical equipoise was first articulated in 1987 by Benjy Freedman. Briefly, the principle holds that trials should never randomize patients to interventions that are viewed by the expert community as demonstrably inferior. Clinical equipoise embodies both ethical and epistemic propositions. With respect to the former, it holds that caregivers should never violate their duty of care when conducting clinical research. The epistemic element is that trials should only be initiated within a zone of maximum uncertainty among a community of experts about the merits of a treatment against an established care standard.
As a concept, clinical equipoise has enjoyed a career like few others in bioethics. Freedman’s original article has logged over 800 citations according to Web of Science. The concept is endorsed in various official policies, including those of Canada, New Zealand, and the National Bioethics Advisory Committee. It has also taken root in many clinical trial textbooks. Meantime, clinical equipoise has been applied as a design principle for nonrandomized trials and studies of public health interventions.