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Commentary

Ethics of randomised controlled trials – not yet time to give up on equipoise

Richard E Ashcroft

Author Affiliations

Medical Ethics Unit, Imperial College London, London, UK

Arthritis Res Ther 2004, 6:237-239  doi:10.1186/ar1442

Published: 14 September 2004

Abstract

In this commentary on Fries and Krishnan's argument that 'design bias' undermines the status of equipoise as the ethical justification for randomised controlled trials, it is argued that their argument is analogous to Bayesian arguments for the use of informative priors in trial design, but that this does not undermine the importance of equipoise. In particular, mismatches between the outcomes of interest to industrial sponsors of research and outcomes of interest to patients and clinicians ensure that in many cases industry-sponsored trials can fail to reflect the reasonable equipoise of working clinicians.

Keywords:
design bias; ethical principles; expected outcomes; randomised controlled trials