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• Meyer, R.E. et al.(2010) Suicidality and risk of suicide--definition, drug safetyconcerns, and a necessary target for drug development: A brief report. J ClinPsychiatry 71, 1040-6.• Oquendo, M.A., Halberstam, B. & Mann, J.J.(2008) Columbia Suicide HistoryForm. In: Handbook of Psychiatric Measures, Vol. 2nd (eds. Rush, J., First, M.B.and Black, D.) 241-2 (American Psychiatric Publishing, Inc;, Washington, D.C.• Osman, A., Bagge, C.L., Gutierrez, P.M., Konick, L.C., Kopper, B.A. & Barrios,F.X. (2001) The Suicidal Behaviors Questionnaire-Revised (SBQ-R): Validationwith clinical and nonclinical samples. Assessment 8, 443-54.• PhRMA White Paper, December 2008, on the Assessment of Suicidality ,December 19, 2008. On file upon request.• Posner, K., Oquendo, M., Gould, M., Stanley, B. & Davies (2007), M. ColumbiaClassification Algorithm of Suicide Assessment (C-CASA): Classification ofsuicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. AmJ Psychiatry 164, 1035-43.• Posner, K., Melvin, G.A., Stanley, B., Oquendo, M.A. & Gould, M.(2007)Factors in the assessment of suicidality in youth. CNS Spectr 12, 156-62.• Stone, M. et al. (2009) Risk of suicidality in clinical trials of antidepressants inadults: analysis of proprietary data submitted to US Food and DrugAdministration. BMJ 339, b2880.Muncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson40
• Berlin and Colditz (1999). The role of meta-analysis in the regulatory process forfoods, drugs, and devices. JAMA; 281:830-834.• Berry, S. & Berry, D. (2004) Accounting for multiplicities in assessing drug safety:a three-level hierarchical mixture model. Biometrics 60, 418-26• Bradburn MJ, Deeks J, Berlin JA, and Localio AR (2007). Much ado aboutnothing: a comparison of the performance of meta-analytical methods with rareevents. Statistics in Medicine; 26:53-77• Breslow, N.E. & Day, N.E. Statistical method in cancer research; vol 1. TheAnalysis of Case Control Studies (Oxford University Press: 1980).• Crowe BJ, et al., (2009), Recommendations for safety planning, data collection,evaluation and reporting during drug, biologic and vaccine development: a reportof the safety planning, evaluation, and reporting team. Clin Trials; 6: 430-440.• DerSimonian, R. & Laird,(1986) N. Meta-analysis in clinical trials. Control ClinTrials 7, 177-88.• DuMouchell, W.(1999) Bayesian data mining in large frequency tables, with anapplication to the FDA spontaneous reporting system. Am Stat 53, 177-90.Muncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson41
Page 1 and 2: Past, present, and future34 th Annu
Page 3 and 4: • Research question in clinical t
Page 5 and 6: Is suicidalitythe right term ?Munci
Page 7 and 8: Where we wereWhere we areWhere we a
Page 9 and 10: • 2008- 2009• PhRMA* Working gr
Page 11 and 12: • September 2010• FDA Draft Cli
Page 13 and 14: C-CASA=classification system1. Comp
Page 15 and 16: • Since 2009The statistical sub t
Page 17 and 18: • Contribute the scientific dialo
Page 19 and 20: Collection of suicide-related dataI
Page 21 and 22: www.cssrs.columbia.edu/scales_cssrs
Page 23 and 24: • Suicide-related endpoints• Tr
Page 25 and 26: • Definition of treatment-emergen
Page 27 and 28: Recent HistoryAll prior History =Li
Page 29 and 30: • Suicidal behaviors have no “n
Page 31 and 32: • Time-to-event analyses• Time-
Page 33 and 34: • Establish criteria for studies
Page 35 and 36: • No uniformly “best” method
Page 37 and 38: Muncie, IN May 25, 2011 C. Gassmann
Page 39: • Beck, A.T., Kovacs, M. & Weissm
Page 43 and 44: • Pintilie, M. Competing risks: a

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