@article{ref1,
title="Clinical and statistical assessment of suicidal ideation and behavior in pharmaceutical trials",
journal="Clinical pharmacology and therapeutics",
year="2011",
author="Gassmann-Mayer, C. and Jiang, K. and McSorley, P. and Arani, R. and Dubrava, S. and Suryawanshi, S. and Webb, D. M. and Nilsson, M.",
volume="90",
number="4",
pages="554-560",
abstract="In the past two decades, the potential association between the risk of suicidal ideation and behavior and the clinical use of pharmaceutical products has been debated among industry, regulators, and academia. A better understanding of the possible effects-favorable, unfavorable, or neutral-of pharmaceuticals on the risk of suicidal ideation and behavior may be required, especially for trials typically designed for other primary objectives. Here, a cross-industry statistical team provides recommendations that address the assessment, statistical analysis, interpretation, and utility of suicide-related data in pharmaceutical clinical trials. These recommendations are to evaluate suicidal ideation, suicidal behavior, and the two combined as end points; utilize standard scales to collect data prospectively; and analyze the data using several statistical methods. A more accurate assessment of the potential association between the use of pharmaceutical products and risk of suicide-related events will contribute to estimating the benefit/risk ratio and result in safer medicines for patients.<p /><p>Language: en</p>",
language="en",
issn="0009-9236",
doi="10.1038/clpt.2011.144",
url="http://dx.doi.org/10.1038/clpt.2011.144"
}