Analytical and Statistical Considerations for Prospectively Collected Data on Suicidal Thoughts and Behaviors
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Ramin Arani, Astellas Inc.   Sarah Dubrava, Pfizer, Inc.  Cristiana Gassmann-Mayer, Johnson & Johnson  Kaihong Jiang, Sanofi-Aventis  Paul McSorley, GlaxoSmithKline  *Mary Nilsson, Eli Lilly & Company  Shailaja Suryawanshi, Merck & Co., Inc.  

Keywords: Suicide, C-SSRS

Per the September 2010 FDA draft guidance, prospective collection of suicidal thoughts and behaviors is recommended for several classes of medications. Requests were received from the FDA for some compounds starting in 2009. Thus, many clinical trials have included or will include a prospective instrument such as the Columbia Suicide Severity Rating Scale (C-SSRS). A cross-industry statistical team convened to develop analytical and statistical guidance for prospectively collected data on suicidal thoughts and behaviors. This presentation will provide a summary of the industry guidance, define proposed endpoints developed in consultation with medical colleagues and discuss statistical approaches for analysis of data within individual clinical trials and across trials. Although based on data collected using the C-SSRS, the methods may be broadly applicable to other instruments.