Literature DB >> 2033628

At what level of collective equipoise does a clinical trial become ethical?

N Johnson1, R J Lilford, W Brazier.   

Abstract

It has often been argued that if a clinician cannot decide which of two treatments to offer, a trial may be ethical, but it is unethical if she/he has a preference. Since individual clinicians usually have a preference, most trials could be judged unethical according to this line of argument. A recent important article in the New England Journal of Medicine argued that individual preferences are not as important as the collective uncertainty of informed clinicians. If clinicians are equally divided, there is a state of collective equipoise and a trial is ethical. However, clinicians will seldom be exactly equally divided. We conducted an ethometric study to find out how much collective equipoise can be disturbed before the potential subjects in a trial think that it is unethical. Half of our subjects perceived a trial as unethical when equipoise was disturbed beyond 70:30. In other words, when 70 per cent of experts favour one treatment, 50 per cent of subjects would prefer that treatment to be administered rather than subjected to critical assessment. When equipoise is disturbed beyond 80:20, less than 3 per cent of subjects would consider human trials morally justifiable.

Entities:  

Keywords:  Analytical Approach; Biomedical and Behavioral Research; Empirical Approach

Mesh:

Year:  1991        PMID: 2033628      PMCID: PMC1375968          DOI: 10.1136/jme.17.1.30

Source DB:  PubMed          Journal:  J Med Ethics        ISSN: 0306-6800            Impact factor:   2.903


  5 in total

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Authors:  R J Lilford
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Authors:  R J Lilford; N Johnson
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Authors:  H K Beecher
Journal:  N Engl J Med       Date:  1966-06-16       Impact factor: 91.245

4.  Ethics and human experimentation. Henry Beecher revisited.

Authors:  D J Rothman
Journal:  N Engl J Med       Date:  1987-11-05       Impact factor: 91.245

5.  The framing of decisions and the psychology of choice.

Authors:  A Tversky; D Kahneman
Journal:  Science       Date:  1981-01-30       Impact factor: 47.728

  5 in total
  39 in total

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Review 6.  Is there a role for preference assessments in research on quality of life in oncology?

Authors:  J E Till; H J Sutherland; E M Meslin
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Authors:  Benjamin Djulbegovic
Journal:  Am J Med Sci       Date:  2011-10       Impact factor: 2.378

8.  Ethics and statistical methodology in clinical trials.

Authors:  C R Palmer
Journal:  J Med Ethics       Date:  1993-12       Impact factor: 2.903

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10.  Challenges of randomized controlled trial design in plastic surgery.

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