Reply to Failure Rate and “Professional Subjects” in Clinical Trials of Major Depressive Disorder
J Clin Psychiatry 2011;72(9):1284-1285 [letter]
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Letter to the Editor
Because this piece does not have an abstract, we have provided for your benefit the first 3 sentences of the full text.
We acknowledge the potential contribution of “professional patients” to the rising placebo response, declining treatment effect over time, and persistently high failure rate seen in placebo-controlled major depressive disorder (MDD) trials. Unfortunately, there are no systematic data to document the impact that such subjects might have. The US Food and Drug Administration (FDA) has little capacity to investigate this concern, because patients are deidentified in the data submitted as part of new drug applications.