Title: On the Statistical Challenges Associated with Prospective Assessment of Suicidality in Clinical Trails
*Antonio Paredes, Food and Drug Administration 

Keywords: Suicidality

The Food and Drug Administration (FDA) recently released a draft guidance reflecting the agency current thinking on prospective assessment of suicidality in clinical trials. The agency is currently working on developing a companion technical guidance addressing data recommendations for suicidality submission to the FDA, as well as statistical methods for the assessment of suicidality. This talk will focuses on the statistical challenges in assessing suicidality data arising from clinical trials.