Clinical Equipoise


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A state of genuine uncertainty as to the advantages or disadvantages of each therapeutic arm in a clinical trial
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Although the similarity position, bolstered by clinical equipoise, became the reigning paradigm in the ethics of clinical trials, its dominion over practice was limited.
If the research subject who is ill has any interests at all, first among these must be to receive competent medical care, as required by clinical equipoise.
Clinical equipoise provides a framework for determining whether a trial meets the physician's ethical obligation to act in the patient's best interest, allowing physician-investigators to participate without compromising their moral, legal, and professional duties to patients.
Part of the problem with defending clinical equipoise has to with its common meaning.
To water down its force by holding that exploitation is an easily overridden concern would merely confirm the worries of those who fear that the shift from clinical equipoise to the antiexploitation norm constitutes an objectionable weakening of the ethical standards of research.
Lynn Jansen examines the implications of the "antiexploitation norm" that Frank Miller and Howard Brody had proposed previously in these pages as a partial replacement for another research norm that they thought seriously confused, that of "clinical equipoise." Jansen shows that "bad deal trials"--trials not in the best interest of at least some research subjects--would be unethical under the norm of clinical equipoise but not necessarily under the antiexploitation norm.
To the Editor: Lynn Jansen makes a strong case for weaning institutions off clinical equipoise, but she errs on the side of being too critical of her own arguments.
Brody, "A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials," Hastings Center Report 33, no.
This is a reason for requiring that a trial be conducted only when the experimental regimen is in clinical equipoise with standard practice.
For uterus transplantation, the risks seem to be justifiable only if clinical equipoise exists--that is, if the risk-benefit ratio of the experimental procedure can reasonably be assumed to be equal to existing alternatives.
The therapeutic orientation, as reflected, for example, in the doctrine of clinical equipoise, provides dubious ethical guidance for these issues.
The principle of clinical equipoise was advanced to allow physician-investigators to meet both therapeutic and research-based obligations.

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