title: Clinical and statistical assessment of suicidal ideation and behavior in pharmaceutical trials.
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.
authors.affiliation: Clinical Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, USA.
authors.forename: C
authors.initials: C
authors.lastname: Gassmann-Mayer
authors.forename: K
authors.initials: K
authors.lastname: Jiang
authors.forename: P
authors.initials: P
authors.lastname: McSorley
authors.forename: R
authors.initials: R
authors.lastname: Arani
authors.forename: S
authors.initials: S
authors.lastname: Dubrava
authors.forename: S
authors.initials: S
authors.lastname: Suryawanshi
authors.forename: D M
authors.initials: DM
authors.lastname: Webb
authors.forename: M
authors.initials: M
authors.lastname: Nilsson
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards / Q000706:statistics & numerical data*; D006801:Humans; D004364:Pharmaceutical Preparations; D011446:Prospective Studies; D059020:Suicidal Ideation; D013406:Suicide, Attempted / Q000517:prevention & control / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations