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J Clin Psychiatry. 2011 Oct;72(10):1350-2. doi: 10.4088/JCP.10com06607whi.

Another point of view: superiority, noninferiority, and the role of active comparators.


Despite substantial agreement with points made by Andrew C. Leon, PhD, in his article, I am not in complete agreement in a few areas. The definition of noninferiority proposed by Leon allows drugs somewhat less effective than placebo to be characterized as noninferior to placebo, and 2 active drugs may each be simultaneously noninferior to the other. Moreover, including a placebo arm in comparing 2 active drugs is of no use in deciding whether the study is well designed or not, since a significant difference between one of the active arms and the placebo may be due to chance or to a bias in the design. An alternative view of the situation is presented.

© Copyright 2011 Physicians Postgraduate Press, Inc.

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