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Activity Number: 77 - Contributed Poster Presentations: Biopharmaceutical Section
Type: Contributed
Date/Time: Monday, August 3, 2020 : 10:00 AM to 2:00 PM
Sponsor: Biopharmaceutical Section
Abstract #312223
Title: Curtailed Binomial Sampling Design for Clinical Trials with Two Dependent Endpoints
Author(s): Chishu Yin* and Pinyuen Chen
Companies: Syracuse University and Syracuse University
Keywords: Clinical trials; dependent binary endpoints; two-stage designs; curtailed sampling design
Abstract:

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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