Evaluation of Performance of Some Enrichment Designs Dealing with High Placebo Response in Psychiatric Clinical Trials
View Presentation *Yeh-Fong Chen, FDA Keywords: placebo response, enrichment design A widely-used design strategy for dealing with the high placebo response commonly observed in trials of psychiatric disorders is to implement a placebo lead-in phase prior to randomization. In recent years, alternative strategies—including a sequentially parallel design (Fava et al., 2003) and a two-way enriched clinical trial design (Ivanova and Tamura, 2011) containing two consecutive double-blind treatment stages—have been proposed. The advantage of these new designs over the traditional placebo lead-in, however, is not always clear. In this presentation, I will discuss the features of these designs, focusing particularly on the evaluation of their performance with respect to continuous measures. In addition to sharing my view on their effectiveness, I will offer suggestions for possible improvement.
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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