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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But this conclusion is precisely what Miller and Brody challenge by rejecting the requirement of clinical equipoise.
Without answers to these questions, we cannot know whether a shift from clinical equipoise to the antiexploitation norm would constitute an objectionable weakening of the ethical standards of clinical research.
To the Editor: Lynn Jansen's article is the latest in a series of pieces challenging the demand for clinical equipoise in research.
What is refreshing about Jansen's article and the other recent challenges to clinical equipoise is that they take us back to the moral basics.
61) We draw a different conclusion from the close relationship between the relative interpretation of minimal risk (which governs "non-therapeutic" research) and the standard of clinical equipoise (which governs "therapeutic" research) asserted in Section 1 (C1) of the Tri-Council Policy Statement.
The impact of clinical equipoise on research ethics policy has been profound.
The literature does not, however, address CRTs of the kind we envision, in which the agents being compared are standard treatments that stand in clinical equipoise.
The therapeutic orientation in the guise of the principle of clinical equipoise categorically rules out the use of placebo controls when proven effective treatments exist for the disorder under investigation.
We argued that clinical equipoise is misguided because it attempts to bring the ethics of clinical trials within the orbit of the ethics of the physician-patient relationship governing medical therapy, despite the fundamental differences between the aims and methods of clinical research and medical care.
To the Editor: Franklin Miller and Howard Brody's rejection of clinical equipoise and the therapeutic obligation is unsound.
Our approach to the ethical analysis of risk, which applies separate standards for the moral evaluation of therapeutic and nontherapeutic procedures in clinical research and accords clinical equipoise a key role, merely formalizes the approach that the commission took in Institutional Review Boards and The Belmont Report.
The prevailing ethical perspective on clinical trials holds that physician-investigators can discharge their "therapeutic obligation" to patients in the context of randomized clinical trials (RCTs) as long as treatments being tested scientifically satisfy clinical equipoise.

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