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Activity Number:
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419
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Type:
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Contributed
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Date/Time:
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Wednesday, August 1, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309582 |
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Title:
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Assessment of the Placebo Effect in Quality-of-Life Evaluations
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Author(s):
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Jens Eickhoff*+
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Companies:
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University of Wisconsin-Madison
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Address:
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610 Walnut St 250 WARF, Madison, WI, 53726,
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Keywords:
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Cardiovascular clinical trial ; mixture modeling ; EM-algorithm
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Abstract:
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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, very sensitive to the placebo effect. The placebo effect has led to dramatic consequences on the clinical development of new therapeutic agents. A mixture regression model 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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