Such an investigation is needed to assess the plausibility of the suggestion that the antiexploitation norm is a genuine alternative to clinical equipoise for regulating clinical research.
Not every clinical trial poses a t N problem under the requirement of clinical equipoise.
If clinical equipoise is not relevant, why should treatment be the yardstick against which clinical trials are measured?
Finally, I want to emphasize that debate about the value of clinical equipoise applies only to phase III randomized controlled trials designed to determine the ultimate treatment-worthiness of studied interventions.
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).
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
Contrary to the doctrine of clinical equipoise
, such studies are not necessarily unethical.
Rather than rejecting clinical equipoise
, which addresses uncertainty in the community of expert physicians, we should extend the concept of uncertainty to our conversations with potential patient-participants, in which (1) the clinical and social relevance of the uncertainty being addressed is explicated, and (2) the notion of patient equipoise is clarified.
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).
bridges the norms of clinical practice and clinical research.
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?