Citation

Gassmann-Mayer C, Jiang K, McSorley P, Arani R, Dubrava S, Suryawanshi S, Webb DM, Nilsson M. Clin. Pharmacol. Ther. 2011; 90(4): 554-560.

Copyright

(Copyright © 2011, American Society for Clinical Pharmacology and Therapeutics, Publisher Nature Publishing Group)

DOI

10.1038/clpt.2011.144

PMID

21775982

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.

Language: en

Keywords

Humans; Prospective Studies; Suicidal Ideation; Suicide, Attempted; Surveys and Questionnaires; Pharmaceutical Preparations; Clinical Trials as Topic