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October 3, 2001

Ethical Issues in the Reporting of Clinical Trials

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;286(13):1577-1578. doi:10.1001/jama.286.13.1573

To the Editor: We hope the revised CONSORT statement will contribute to further improvements in the reporting of unbiased results of randomized controlled trials (RCTs).1 However, the CONSORT statement continues to neglect one of the most important aspects of the design and conduct of RCTs: the choice of an adequate control group.2 A randomized trial can adhere to all of the CONSORT statement's recommendations and yet still be biased if the investigators have selected an inferior comparator intervention for their control group.3,4 For example, it was recently shown that studies sponsored by pharmaceutical companies were judged superior or equal to studies funded by public resources for the most of the quality items incorporated in the CONSORT statement.4,5 However, these studies were potentially biased by more frequent use of a placebo/no therapy control group as a comparator. One way to ensure that an adequate control group is used lies in the explicit acknowledgment of the uncertainty about the relative effects of all the interventions to be compared in a randomized trial.3 This is usually expressed in terms of the "uncertainty principle," which states that a patient should be enrolled in a randomized trial only if there is substantial uncertainty about which of the trial interventions would benefit the patient more.6