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Paredes, Food and Drug Administration Keywords: Suicidality The Food and Drug Administration (FDA) recently released a draft guidance reflecting the agency current thinking on prospective assessment of suicidality in clinical trials.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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC