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Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 2: Practical Issues and Specific Cases
- Susan S. Ellenberg, PhD; and
- Robert Temple, MD
- From the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland.
Abstract
Placebo controls are commonly used in clinical trials of investigational treatments because they have important advantages. In recent years, some have criticized the use of placebo-controlled trials when effective alternative therapy exists, regardless of the expected effect of the therapy. In part 1 of this paper, ethical arguments are addressed and the interpretive problems inherent in the use of active-control equivalence trials to establish efficacy of a new treatment are clarified. However, uncertainties may complicate decisions about appropriate use of placebo controls in some situations. Part 2 discusses more fully the ethical considerations for using placebo controls in particular medical settings. The value and relevance of placebo-controlled trials of new agents in situations in which proven effective therapy is available are also explored.
- Placebos
- Clinical trials, double-blind method
- Ethics, medical
- Informed consent
- Outcome assessment (health care)
Article and Author Information
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Acknowledgments: The authors thank Drs. Jay Siegel, Marc Walton, Janet Wittes, William Schwieterman, and Mary Foulkes for helpful comments on earlier versions of this manuscript.
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Requests for Single Reprints: Susan Ellenberg, PhD, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852.
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Current Author Addresses: Dr. Ellenberg: Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852.
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Dr. Temple: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 5600 Fishers Lane, HFD-101/WOC II—6014, Rockville, MD 20857.
- Copyright ©2004 by the American College of Physicians
