Clinical Equipoise
Definition
The state in which there is genuine uncertainty in the expert medical community over whether a treatment will be beneficial (Wikipedia Definition).
What is clinical equipoise?
Genuine uncertainty in the expert medical community over whether a treatment will be beneficial.
Developed to answer when a clinician can run a controlled trial without violating the obligation to give best treatment — the control arm may get substandard care, placebo, or nothing.
In essence it was developed in response to the question of when can clinicians conduct controlled clinical trials without violating an obligation to provide the best medical treatment. In particular the participants in the control arm might receive substandard care (possibly no treatment or a placebo) (Hey et al. 2017).
Ethical Dilemma of Clinical Equipoise
When the investigator(s) begin to believe that the treatment or intervention administered in one arm of the trial is significantly outperforming the other arms, there is an ethical dilemma. After a certain point, findings may provide sufficient evidence to convince the invetigator of the intervention’s efficacy and so there is no longer genuine uncertainty about the most beneficial treatment. Hence, there is an ethical imperative at this point in the study for the investigator to provide the superior intervention to all participants.
One point of contention of ethicists is the location of this evidentiary threshold, where some believe:
- Study should continue until the investigators themselves are convinced of the better treatment
- Study should continue until the wider medical community is convinced of the better treatment
Relevance to Research
Another point of contention is whether it is relevant to research at all. This is debated in (Hey et al. 2017), where it is argued that perhaps clinical equipoise is not relevant since many studies contain some inherit risk. In particular to upheld clinical equipoise completely there would have be absolute uncertainty about the most efficacious treatment (or lack thereof) that each arm of a study receives. This is perhaps more confounded by the concept of personal equipoise (Cook and Sheets 2011).
What is the ethical dilemma that arises during a trial held under clinical equipoise?
Once the investigator believes one arm is significantly outperforming the others, there is no longer genuine uncertainty — so there’s an ethical imperative to give the superior intervention to everyone.
Ethicists disagree about where that evidentiary threshold sits.
Cite this note
@online{hoque2021clinical,
author = {Sabiqul Hoque},
title = {Clinical Equipoise},
year = {2021},
url = {https://sabicool.github.io/Braindump/notes/20211222235900-clinical_equipoise.html},
organization = {Braindump}
}