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Activity Number: 44 - Innovative Clinical Trial Designs and Analytic Methods in Neuroscience
Type: Invited
Date/Time: Sunday, July 29, 2018 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract #326759 Presentation
Title: New Developments with the Sequential Parallel Comparison Design
Author(s): Gheorghe Doros* and Denis Rybin
Companies: Boston University and Pfizer, Inc
Keywords: Placebo Response; Sequential Parallel Comparison Design; EM Algorithm

Placebo response can affect the inference about efficacy of the studied treatment. Criterion-based classification may lead to classification error and bias the inference. The uncertainty about placebo response characteristic has to be factored into the treatment effect estimation. We propose a robust way to classify trial subjects with respect to their response to placebo. This approach views the placebo response as a latent characteristic and the study sample as an unlabeled mixture of 'placebo responders' and 'placebo non- responders'. The likelihood-based methodology is utilized to estimate the treatment effect corrected for placebo response as defined within Sequential Parallel Comparison Design.

Authors who are presenting talks have a * after their name.

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