Choosing a control intervention for a randomised clinical trial

BMC Med Res Methodol. 2003 Apr 22:3:7. doi: 10.1186/1471-2288-3-7. Epub 2003 Apr 22.


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.

MeSH terms

  • Control Groups*
  • Humans
  • Patient Selection
  • Randomized Controlled Trials as Topic / methods*