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Activity Number:
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151
- Enrichment Clinical Trials: Novel Designs, Statistical Inferences, and Case Studies
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 31, 2017 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #322808
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View Presentation
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Title:
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Enrichment by Response: Sequential Parallel Comparison Design
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Author(s):
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Anastasia Ivanova*
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Companies:
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UNC at Chapel Hill
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Keywords:
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SPCD ;
Placebo Response
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Abstract:
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The sequential parallel comparison design (SPCD) is a two-stage design recommended for trials with possibly high placebo response. In the first stage subjects are randomized between active therapy and placebo. In the second stage placebo patients are re-randomized between active therapy and placebo. To reduce placebo response the analysis population is enriched in the second stage and only data from stage 1 placebo non-responders are used. Data from both stages are pooled for the primary analysis. The SPCD can be beneficial in psychiatry, gastroenterology, neurology and other areas. We present case studies with the SPCD and review recent developments in statistical methodology related to the SPCD.
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Authors who are presenting talks have a * after their name.
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