Debate

Choosing a control intervention for a randomised clinical trial

Howard Mann¹ and Benjamin Djulbegovic²

¹Department of Radiology 1A71 University Hospital 50 North Medical Drive Salt Lake City UT 84132

²H. Lee Moffitt Cancer Center & Research Institute University of South Florida Department of Interdisciplinary Oncology 12902 Magnolia Drive Tampa FL 33612

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BMC Medical Research Methodology 2003, 3:7doi:10.1186/1471-2288-3-7

Published:	22 April 2003

Abstract

Background

Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated.

Discussion

We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol.

Summary

When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.