Past, present, and future - MBSW Online

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• Cristiana Gassmann-Mayer is an employee ofJohnson & Johnson• The views and comments presented here a solelythose of the presenter and not necessarilyrepresentative of those ofJohnson & Johnson or PhRMA organization• Several slides are adapted from the presentationto the FDA of April 4, 2011 (courtesy of MaryNilsson, Eli Lilly)Muncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson 2
• Research question in clinical trials• Terminology• General background• Role of statisticians• Data collection: from retrospective toprospective scales• Statistical concepts and remaining areasfor debate• ConclusionsMuncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson 3
Page 1: Past, present, and future34 th Annu
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 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

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