Choosing a control intervention for a randomised clinical trial

• Main Authors: Djulbegovic Benjamin, Mann Howard
• Format: Article
• Language: English
• Published: BMC 2003-04-01
• Series: BMC Medical Research Methodology
• Online Access: http://www.biomedcentral.com/1471-2288/3/7

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Summary</p> <p>When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.</p>