Past, present, and future - MBSW Online

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• Be consistent with Sponsor standards; usesame statistical approach as for other safetyassessments• No adjustments for multiplicity typically in asingle trial• No inferential statistics except where indicated,otherwise exact tests; 95%CIs are recommended• Metrics: at least one analysis using odds ratio andone using risk differencePeto ORMantel-Haenszel risk differenceArcsine differenceMuncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson30
• Time-to-event analyses• Time-to-event analyses may not be appropriatefor trials of short duration, when there are longtime intervals between scale collections, or due to“informative censoring” situations• Interpret with caution – Need to understandassumptions• Exposure-adjusted analyses• Consider Exposure Adjusted Incidence Rates, fortaking into account variable duration of exposureMuncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson31
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
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Page 13 and 14: C-CASA=classification system1. Comp
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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: • Suicidal behaviors have no “n
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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