Past, present, and future - MBSW Online

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• Last 2 decades• Early 1990’s : SSRI’s in adults with depression• 2002-2008 SSRIs in pediatric populationand anti-epileptics, treatments of psychiatrydisorders, smoking cessation therapy, obesity,anti-allergy, etc.• Retrospective assessment of adverse eventsdata resulted in multiple label changes and black box warning• 2007• Dr. Kelly Posner and U of Columbia : Columbia- ClassificationAlgorithm of Suicide Assessment (C-CASA)Muncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson8
• 2008- 2009• PhRMA* Working group: consensuson the assessment, analysis andreporting of suicide-related data• 2009• PhRMA white paper tothe FDA in January 2009• 2009-2010• Statistical sub-team continuedworking independently of PhRMA* Pharmaceutical Research and Manufacturers of AmericaMuncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson9
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: Where we wereWhere we areWhere we a
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 and 40: • Beck, A.T., Kovacs, M. & Weissm
Page 41 and 42: • Berlin and Colditz (1999). The
Page 43 and 44: • Pintilie, M. Competing risks: a

Past, present, and future - MBSW Online

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