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BMC Med Res Methodol. 2003 Apr 22;3:7. Epub 2003 Apr 22.

Choosing a control intervention for a randomised clinical trial.

Author information

  • 1Department of Radiology, 1A71 University Hospital, 50 North Medical Drive, Salt Lake City, UT 84132, USA. howard.mann@hsc.utah.edu

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.

PMID:
12709266
PMCID:
PMC165581
DOI:
10.1186/1471-2288-3-7
[PubMed - indexed for MEDLINE]
Free PMC Article
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