|
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
|
|
Abstract:
|
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.
