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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

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

Dear Editor,

I read with interest the article by Hey et al (2017) describing arguments for and against the relevance of clinical equipoise in the justification of clinical trials. However, I disagree with the assertion that differing ethical premises in clinical research and clinical practice mean that clinical equipoise inappropriately aligns practice standards in these two fields. Essentially, the authors suggest that the obligation to provide competent clinical care to all patients in a trial distracts from the purpose of a trial to identify clinically useful information. However, I would suggest that enforcement of the clinical equipoise principle aligns clinical research and practice advantageously by obliging researchers to ask only questions most relevant to clinical practice.

By requiring genuine uncertainty regarding the relative efficacy of treatments in both arms of a trial, clinical equipoise provides a strong imperative to compare new treatments to the current gold standard for that disease. This is relevant where new treatments may be superior to placebo, but unless they are superior to established treatments they will offer little additional value to clinical practice. Furthermore, clinical equipoise provides a clear standard in this area compared to alternative models such as the net risks model where a variety of variables are considered to justify a trial. Thus, while I must concede that clinical equipoise constrains the conduct of clinical researchers, it does not necessarily do so to the detriment of scientific progress.

Competing interests: No competing interests

01 January 2018
Sheila M McSweeney
Clinical Fellow in Dermatology
St. John's Institute of Dermatology
London, UK