Past, present, and future - MBSW Online

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Include: Stratification by study Sensitivity analyses (eg. mixed effects vs fixed effects) Also studies with no events DerSimonian-Laird test (r<strong>and</strong>om effects) Exact meta-analytic approach that combines confidencedistributions to estimate the risk difference CI withoutcontinuity correction Pay attention to continuity correctionsSt<strong>and</strong>ard 0.5 correction is NOT recommendedOther corrections are preferredMuncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson34
• No uniformly “best” method• Need for pre-specified safetyanalysis plans• Need for sensitivityanalyses• Need for cautionMuncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson35
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: • Establish criteria for studies
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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