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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Firstly, the "therapeutic component" (21) of a research study (the experimental agent and all that belongs to its administration) must be justified by its standing in clinical equipoise with the current standard treatment.
Clinical equipoise has clear implications for use of placebo controls in RCTs.
As described above, the form of CRT whose acceptability we were studying compares two accepted treatments for which a state of clinical equipoise exists.
Contrary to the doctrine of clinical equipoise, such studies are not necessarily unethical.
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.
Two in particular, David Orentlicher's proposal to make some standard treatments available only through research participation and Lynn Jansen's analysis of the ethical acceptability of "bad deal trials" CA Closer Look at the Bad Deal Trial: Beyond Clinical Equipoise," HCR, Sept-Oct 2005), especially deserve comment because they address an important, long-standing issue: the similarity--or lack thereof--between clinical research and medical treatment.
In an important recent article, Franklin Miller and Howard Brody argued that we should reject the concept of clinical equipoise as an ethical requirement for regulating clinical research.
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.
Most commentators have held that clinical equipoise must obtain if a trial is to be ethical.
To the Editor: I am no great fan of clinical equipoise (Frank Miller and Howard Brody, "A Critique of Clinical Equipoise," HCR, May-June 2003).
To the Editor: Miller and Brody provide an insightful and informative historical account of the development of the clinical equipoise concept in the randomized controlled trial (RCT) ("A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials," May-June 2003).
Clinical equipoise bridges the norms of clinical practice and clinical research.

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