The phrase "thought to be at least as good as current therapy," when used as a summary of clinical equipoise, gives little prominence both to the very real possibility that the new intervention may be worse than the current standard of care, and to the fact that the basis on which it is thought to be "at least as good" is less secure than the basis for our belief in the current standard of care (evidence for the new intervention may be anecdotal, or take the form of case studies, or consist in trials in animal and other models).
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.
His argument depends on clinical equipoise
and amounts to asserting that there is no difference between research and treatment in these trials.
Miller and Brody contend that clinical equipoise
should be rejected because the context of clinical research is fundamentally different from the context of medical therapy.
David Orentlicher's proposal for compulsory research participation would not require modifying or abandoning informed consent or clinical equipoise
To the Editor: Franklin Miller and Howard Brody's rejection of clinical equipoise
and the therapeutic obligation is unsound.
The notion, implicit in Miller and Brody's renunciation of clinical equipoise
, that the thousands of patients needed each year for RCTs need to be persuaded to renounce their personal medical interests is untenable.
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.
But if clinical equipoise
is a basic requirement for ethical research, how could all these review boards be blind to the unethical nature of this trial?