TY  - JOUR
PY  - 2011//
TI  - Clinical and statistical assessment of suicidal ideation and behavior in pharmaceutical trials
JO  - Clinical pharmacology and therapeutics
A1  - Gassmann-Mayer, C.
A1  - Jiang, K.
A1  - McSorley, P.
A1  - Arani, R.
A1  - Dubrava, S.
A1  - Suryawanshi, S.
A1  - Webb, D. M.
A1  - Nilsson, M.
SP  - 554
EP  - 560
VL  - 90
IS  - 4
N2  - 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>
LA  - en
SN  - 0009-9236
UR  - http://dx.doi.org/10.1038/clpt.2011.144
ID  - ref1
ER  -