Journal
CONTEMPORARY CLINICAL TRIALS
Volume 36, Issue 2, Pages 510-514Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2013.09.003
Keywords
Ethics; Placebo control; Randomized controlled trial
Funding
- Intramural NIH HHS [Z99 CL999999] Funding Source: Medline
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The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. Published by Elsevier Inc.
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