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A. Clinical Equipoise

"....at the start of the trial, there must be a state of clinical equipoise regarding the merits of the regimens to be tested, and the trial must be designed in such a way as to make it reasonable to expect that, if it is successfully conducted, clinical equipoise will be disturbed."1

Clinical equipoise means a genuine uncertainty on the part of the expert medical community about the comparative therapeutic merits of each arm of a clinical trial. The tenet of clinical equipoise provides a clear moral foundation to the requirement that the health care of subjects not be disadvantaged by research participation. 2



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Clinical Equipoise. Indeterminación clínica o Incertidumbre terapéutica. Sobre la base de los datos disponibles, una. comunidad de médicos competentes ...
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Now that I was on my way into the work environment, I was given a second
assignment to devise a situation in clinical equipoise. Clinical equipoise means that
investigators either genuinely do not know the answer to the question that the research is
designed to answer or that there is significant disagreement in the field about the answer
to a research question. For example, research would not be performed to test two
medications when one was known to be more effective. Therefore, I began an extensive
search into equipoise that became much harder than it initially appears because true

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equipoise occurs only occasionally. I created a case about treatments for autism in
children which also appears virtually unchanged in the most recent draft of the course

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Equipoise 'a term used in relation to clinical trials and in justification of randomisation … denotes the state of
mind of clinicians, individually or collectively, who have no rational preference among the treatment options to
be compared … An important aspect is whether the patients or subjects concerned share the clinicians’
equipoise regarding the possible burdens (including side-effects) as well as potential benefits of the
treatments being compared' (Boyd KM, Higgs R and Pinching AJ (eds) (1997) The New Dictionary of
Medical Ethics, BMJ Publishing Group, London).



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