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• Gassmann-Mayer C, et al., (2011), Clinical and Statistical Assessment of Suicidal Ideationand Behavior in Pharmaceutical Trials. Clinical Pharmacology & Therapeutics (accepted)• Greenland, S. and Robins, J.M.(1985) Estimation of a common effect parameter fromsparse follow-up data. Biometrics, 41, 55-68.• Hall, D.B.(2000) Zero-inflated poisson and binomial regression with random effects: a casestudy. Biometrics 56, 1030-9.• Helena Chmura Kraemer (2009) , Events per person-time (incidence rate): A misleadingstatistic? Statist. Med• Higgins, JPT, et al. (2002) Quantifying heterogeneity in a meta-analysis. Statistics inMedicine; 21:1539-1558• ICH E9: Statistical Principles for Clinical Trials (1998). Available from URL:http://www.ich.org/cache/compo/475-272-1.html. Accessed Sept 29, 2008.• Liu, G.F., Wang, J., Liu, K. & Snavely, D.B.(2006) Confidence intervals for an exposureadjusted incidence rate difference with applications to clinical trials. Stat Med 25, 1275-86.• McCulloch, C.E. & Searle (2001), S.R. Generalized linear and mixed models (John Wiley &Sons: New York, 2001).• O’Neill RT (1988). Assessment of safety. Biopharmaceutical Statistics for Drug Development.Peace KE, ed. New York: Marcel Dekker;543–604.Muncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson42
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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 and 40: • Beck, A.T., Kovacs, M. & Weissm
Page 41: • Berlin and Colditz (1999). The

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