In his recent article,1 David Sackett confuses the constructs of clinical equipoise and theoretical equipoise. Clinical equipoise, unlike uncertainty, can never be ”possessed” by individual trialists. It is a collective concept. Instead, individual trialists must ask themselves, after diligent examination of the accumulated evidence, whether clinical equipoise is present. As to whether equipoise is possessed by ethics committees, we would argue that a great number of ethics committees ”practise” clinical equipoise. It is their duty and responsibility to ask for and weigh the evidence surrounding the proposed treatment alternatives. By doing so, they are implicitly invoking the requirement for clinical equipoise.
As Benjamin Freedman wrote, theoretical equipoise is ”conceptually odd and ethically irrelevant.”2 He therefore suggested an alternative: clinical equipoise, a concept that, in our opinion, brilliantly allows the requirement for genuine uncertainty at the level of the medical community to coexist with the possibility of uncertainty at the individual level.
Signatures
Dean Fergusson
Department of Epidemiology & Biostatistics McGill University Montreal, Que.
Paul Hébert
Clinical Epidemiology Unit University of Ottawa Ottawa, Ont.
References
- 1.Sackett DL. Why randomized controlled trials fail but needn‚t: 1. Failure to gain ”coal-face” commitment and to use the uncertainty principle. CMAJ 2000;162(9):1311-4. [PMC free article] [PubMed]
- 2.Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5. [DOI] [PubMed]