Clinical Review

The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals

BMJ 1998; 317 doi: http://dx.doi.org/10.1136/bmj.317.7167.1209 (Published 31 October 1998) Cite this as: BMJ 1998;317:1209
  1. Sarah J L Edwards, research fellowa,
  2. R J Lilford, professor of health services researcha,
  3. J Hewison, senior lecturerb
  1. Department of Public Health and Epidemiology, University of Birmingham, Birmingham B15 2TT
  2. Department of Psychology, University of Leeds, Leeds LS2 9JT
  1. Correspondence to: Ms Edwards
  • Accepted 2 October 1998

Since the introduction of randomised controlled trials, professionals and lay people alike have worried over whether doing this sort of experiment in humans is ethical. It has been argued that participants may be called to sacrifice their own best interests for the benefit of future patients.1 The scientific rationale for conducting a trial rests in collective equipoise, which means that the medical community as a whole is genuinely uncertain over which treatment is best. The key point, however, is that future patients benefit at no cost to participants, provided that participants are in personal equipoise and give informed consent on this basis. In these circumstances, the trial arms are an equally good bet prospectively.2

Summary points

  • Doctors do not seem to take informed consent from competent patients as seriously as they should; ways in which practice might be improved need to be tested empirically

  • Most doctors expressed willingness to enter their patients in trials even when the treatments offered were widely available but were not an equal bet prospectively; the fact that members of thepublic suspect this might undermine their confidence in trials

  • Willingness to undergo randomisation drops as prospective participants are given more preliminary data and as they are made aware of any accumulating evidence of effectiveness

  • A large number of participants, even in phase III trials, emerge from consultations expecting to benefit personally; self interest, rather than altruism, seems to be their motive for participating

Methods

To find out what patients, the general public, and healthcare professionals thought about trials, we undertook a review of the ethics of randomised controlled trials from these perspectives as part of a broader review relating to the ethics of designing and conducting clinical trials.1 We searched BIDS, Medline, and Psychlit (for strategy see the BMJwebsite). There were 61 studies on attitudes …

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