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Abstract Details

Activity Number: 427
Type: Roundtables
Date/Time: Wednesday, August 1, 2012 : 7:00 AM to 8:15 AM
Sponsor: Biopharmaceutical Section
Abstract - #305646
Title: Reducing Placebo Response in Adult and Pediatric Depression Studies
Author(s): Qi Zhang*+
Companies: Eli Lilly and Company
Address: 3924 Dolan Way, Westfield, IN, 46074, United States
Keywords: Placebo Response ; Depression ; Pediatric ; Adult

Depression trails have high failure rate due to high placebo response with even higher placebo response rate in pediatric studies compared with adult studies. In this discussion, we will share some literature regarding the design factors for placebo response in both Adult and Pediatric Depression studies. The common design considerations to reduce placebo response will be discussed which include the utilization of novel design (such as sequential parallel design), the number of sites, placebo randomization ratio, etc. We will also discuss the know predictors for placebo response. Then we will discuss the best design features to use, the difference between adult and pediatric studies regarding placebo response.

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