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Scientific and Ethical Issues in Equivalence Trials
Benjamin Djulbegovic, MD,PhD;
Mike Clarke, DPhil
JAMA. 2001;285:1206-1208.
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Any testing of medical treatments is an exercise in comparison. In a typical clinical trial, 2 treatments are compared to determine which is better or if both are the same. Trials designed to address whether one treatment is better than the other may be called superiority trials, whereas those designed to show that 2 treatments are the same are called equivalence trials. However, the design of both types of trials should depend on the uncertainty principle—a fundamental ethical and scientific principle for conducting randomized controlled trials.1
The article by Staszewski et al2 in this issue of THE JOURNAL is a randomized controlled equivalence trial that compares a triple nucleoside regimen of abacavir-lamivudine-zidovudine with a more conventional regimen of indinavir-lamivudine-zidovudine in treatment-naive patients infected with human immunodeficiency virus (HIV). Although the authors conclude that these 2 regimens are equivalent in achieving the primary end point . . . [Full Text of this Article]
Author Affiliations: Interdisciplinary Oncology Program, Division of Blood and Bone Marrow Transplantation, H. Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa (Dr Djulbegovic); and Cochrane Centre, NHS Research and Development Program, Summertown Pavilion, Oxford, England (Dr Clarke).
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