Freedman's 'Clinical Equipoise' and Sliding-Scale All-Dimensions-Considered Equipoise'

Abstract

It is often claimed that a clinical investigator may ethically participate (e.g., enroll patients) in a trial only if she is in equipoise (if she has no way to ground a preference for one arm of the study). But this is a serious problem, for as data accumulate, it can be expected that there will be a discernible trend favoring one of the treatments prior to the point where we achieve the trial's objective. In this paper, I critically evaluate Benjamin Freedman's 'clinical equipoise' solution to this dilemma. I argue that Freedman actually puts forth at least two distinct contrasts--one in terms of community vs. individual equipoise, and another concerning clinical vs. theoretical equipoise--and that neither of them resolves the dilemma. I then make a proposal for a more adequate account of how to think about the circumstances under which entering subjects in trials would be justified--a 'sliding-scale equipoise' that arises out of a discussion of patients' values.

So-Called "Clinical Equipoise" and the Argument from Design

“…I have been arguing for some time that this so-called "clinical equipoise" solution to this problem is illegitimate (Gifford, 1995(Gifford, , 2000(Gifford, , 2007. I argue that the criterion is importantly ambiguous, but also that there is no "Clinical Equipoise" and the Argument from Design 137 single interpretation according to which it gives us clear and reasonable advice that would solve our problem.…”

“…The first and perhaps most significant of these is the conflation between "clinical" and "community" equipoise (Gifford, 2000). There are then also subtypes of clinical equipoise properly so-called (Gifford, 2000), and, similarly, there are various importantly different interpretations of "community equipoise" (Gifford, 1995).…”

“…There are then also subtypes of clinical equipoise properly so-called (Gifford, 2000), and, similarly, there are various importantly different interpretations of "community equipoise" (Gifford, 1995).…”

“…And if any were unconvinced because they thought I had unfairly substituted community equipoise for clinical equipoise, I explained in (Gifford, 2000) why this was not the case. But while I have not seen responses to my arguments, acceptance of the so-called "clinical equipoise" criterion continues.…”

Timing Invitations to Participate in Clinical Research: Preliminary versus Informed Consent

“…There can be cases in which a clinician thinks he or she has good reason not to be in equipoise not because he or she fails to understand the distinction between research and treatment but because, for example, he or she knows something important about how the treatment under investigation works and the particular patient in question. The concept of equipoise and the role it ought to play in biomedical research have been discussed extensively (see, for example, Ashcroft, 1999;Freedman, 1987;Fried, 1974;Gifford, 2000;Veatch, 2002). One of the prevailing arguments in the research ethics literature is that clinical equipoise is a necessary condition for it to be permissible to conduct a controlled clinical trial, that is, the medical community must not know if one treatment is better than another.…”