Analytical and Statistical Considerations for Prospectively Collected Data on Suicidal Thoughts and Behaviors

• Activity Number: 37
• Type: Contributed
• Date/Time: Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Mary E. Nilsson and Shailaja Suryawanshi*+ and Cristiana Gassmann-Mayer and Sarah Dubrava and Paul A. McSorley and Kaihong Jiang and Ramin Arani
• Companies: Eli Lilly and Company and Merck & Co., Inc. and Johnson & Johnson Pharmaceutical R&D, LLC and Pfizer Inc. and GlaxoSmithKline Beecham and sanofi-aventis and Bristol-Myers Squibb
• Keywords: Suicidality ; Suicidal ideation ; Suicidal behaviors ; Columbia-Suicide Severity Rating Scale

Abstract

Per a recent FDA draft guidance (September 2010), prospective collection of suicidal thoughts/ideation and behaviors is recommended for all compounds that will be reviewed by the Divisions of Psychiatry or Neurology of the FDA, and for compounds that are pharmacologically similar to drugs for which possible signals of risk for suicide-related events have already been identified, including brain-penetrant drugs outside the Central Nervous Systems (CNS) indications such as beta blockers and drugs for smoking cessation, and weight loss. The FDA has indicated that their preferred prospective suicidality collection instrument is one that maps to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories. Thus, many clinical trials will now include a prospective instrument such as the Columbia Suicide Severity Rating Scale (C-SSRS) to accommodate this recommendation. Analytical and statistical approaches will be outlined for data from individual clinical trials and meta-analyses across trials. The focus will be on the methods for C-SSRS data, but will include concepts that can be applied to other scales that can be mapped to C-CASA.