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Open Access Research

Does clinical equipoise apply to cluster randomized trials in health research?

Ariella Binik1, Charles Weijer123*, Andrew D McRae134, Jeremy M Grimshaw56, Robert Boruch7, Jamie C Brehaut58, Allan Donner39, Martin P Eccles10, Raphael Saginur11, Monica Taljaard58 and Merrick Zwarenstein12

Author Affiliations

1 Rotman Institute of Philosophy, Department of Philosophy, University of Western Ontario, London, ON, N6A 5B8, Canada

2 Department of Medicine, University of Western Ontario, 339 Windermere Road, London, ON, N6A 5A5, Canada

3 Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON, N6A 5C1, Canada

4 Division of Emergency Medicine, University of Calgary, Foothills Medical Centre, 1403 29th Street NW, Calgary, AB, T2N 2T9, Canada

5 Ottawa Hospital Research Institute, Clinical Epidemiology Program, Civic Campus, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada

6 Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, K1H 8L6, Canada

7 Graduate School of Education and Statistics Department, Wharton School, University of Pennsylvania, 3700 Walnut Street, Philadelphia, PA, 19104, USA

8 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, ON, K1H 8M5, Canada

9 Robarts Clinical Trials, Robarts Research Institute, London, ON, N6A 5K8, Canada

10 Institute of Health and Society, Newcastle University, 21 Claremont Place, Newcastle upon Tyne, NE2 4AA, UK

11 Department of Medicine, University of Ottawa and Ottawa Hospital, Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada

12 Centre for Health Services Sciences, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada

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Trials 2011, 12:118  doi:10.1186/1745-6215-12-118

Published: 11 May 2011

Abstract

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act?

In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial. Finally, clinical equipoise provides research ethics committees with formal and procedural guidelines that form an important part of the assessment of the benefits and harms of CRTs in health research.