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Activity Number:
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243
- Contributed Poster Presentations: Biopharmaceutical Section
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Type:
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Contributed
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Date/Time:
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Monday, July 31, 2017 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #324193
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Title:
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Sample Size Re-Estimation and Other Midcourse Adjustments with Sequential Parallel Comparison Design
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Author(s):
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Rachel Silverman* and Anastasia Ivanova
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Companies:
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University of North Carolina and UNC at Chapel Hill
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Keywords:
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Placebo respose ;
Sequential Parallel Comparison Design ;
SPCD ;
Sample size re-estimation ;
Adaptive design
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Abstract:
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Sequential parallel comparison design (SPCD) was proposed to reduce placebo response in a randomized trial with placebo comparator. This design is achieved by randomizing subjects between placebo and drug in stage 1 of the trial and then re-randomizing in stage 2 of the trial those subjects who did not respond to placebo in stage 1. Efficacy analysis of the study data includes all data from stage 1 and all placebo non-responding subjects from stage 2. This investigation analyzes the possibility to increase the sample size and adjust the design parameters during an interim analysis; these design parameters include, allocation proportion to placebo in stage 1 of SPCD and weight of stage 1 data in the overall efficacy test statistic.
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Authors who are presenting talks have a * after their name.
