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Is the concept of clinical equipoise still relevant to research?

BMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j5787 (Published 28 December 2017) Cite this as: BMJ 2017;359:j5787

Rapid Response:

Re: Is the concept of clinical equipoise still relevant to research?

Dear Editor,

I did not find merit in Rid and Miller’s arguments that equipoise is unnecessary in clinical trials.[1] I have defined equipoise as the situation where both options offer the patient equal expected utility.[2] This means that when a patient is offered both options and cannot decide, randomisation offers equal expected utility by definition. It does not follow that proponents of equipoise ‘would not object to’ unnecessary tests. Some might not, but this is not a function of the equipoise principle. The best way to think about the issue is to ask yourself this question – “if there was no trial, then what would I tell my patient about the alternatives?” Then, in the trial, that is what the patient should be told. What if one treatment is available only in the trial? In that case, the patient should be given exactly the same information about the treatments (the usual and restricted treatment) and then offered a choice between the usual treatment and the trial. I call this ‘equipoise plus’.

Yours faithfully,
Richard Lilford

References:
1. Rid A, Miller F. Is the concept of clinical equipoise still relevant to research? No. BMJ. 2017; 359: j5787.
2. Lilford RJ. Ethics of clinical trials from a Bayesian and decision analytic perspective: whose equipoise is it anyway? BMJ. 2003; 326: 980.

Competing interests: No competing interests

26 February 2018
Richard J. Lilford
Professor of Public Health
University of Warwick
Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK