Activity Number:
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77
- 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, August 3, 2020 : 10:00 AM to 2:00 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #312223
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Title:
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Curtailed Binomial Sampling Design for Clinical Trials with Two Dependent Endpoints
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Author(s):
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Chishu Yin* and Pinyuen Chen
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Companies:
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Syracuse University and Syracuse University
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Keywords:
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Clinical trials;
dependent binary endpoints;
two-stage designs;
curtailed sampling design
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Abstract:
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We consider testing whether an experimental treatment is superior to a control treatment in clinical trials with two dependent binary endpoints. We study a sequential curtailed two-stage design, which provides the same probabilities of type I and type II errors as does the fixed-sample-size procedure but with a smaller expected sample size. The power function is written in terms of the probability mass function of Bernoulli random variables and it is used to calculate the size and the power instead of using normal approximation to binomial. Numerical comparisons are made to illustrate (1) the savings on the sample size of the proposed two-stage design over the fixed-sample-size procedure and (2) the differences on the sizes and the powers calculated by using the exact Bernoulli distribution and by using normal approximation.
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Authors who are presenting talks have a * after their name.