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Activity Number: 518
Type: Topic Contributed
Date/Time: Wednesday, August 7, 2013 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #309518
Title: Placebo Effect Assessment in Quality-of-Life Evaluations
Author(s): Jens Eickhoff*+
Companies: University of Wisconsin-Madison
Keywords: mixture model ; latent variable modeling ; misclassification
Abstract:

The assessment of Quality of Life (QoL) has become a standard component in many clinical trials. QoL, however, is an inherently subjective measure and, as such, prone to the placebo effect. The placebo effect has led to dramatic consequences on the clinical development of new therapeutic agents. A multivariate mixture regression modeling approach is proposed to assess the placebo effect in a placebo-controlled clinical trial. Simulation studies are conducted to examine the empirical behavior of the proposed method. The approach is illustrated with the analysis of QoL data from a phase III cardiovascular clinical trial.


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