TL46: Ensuring Success in Mood Disorder Trials
Rosanne Lane, Janssen Research & Development, LLC *Pilar Lim, Janssen Research & Development, LLC Keywords: placebo response, mood disorder, expectation bias High placebo response rates have been a major source of difficulty in many mood disorder trials and their effects have been difficult to overcome in developing new compounds. This roundtable session will discuss the following questions: 1. What design strategies have been used to address high placebo response rates? 2. What approaches have been used to reduce investigator and subject expectation bias? 3. Have these designs and approaches been acceptable to regulatory authorities?
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC