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Activity Number: 75
Type: Contributed
Date/Time: Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
Sponsor: General Methodology
Abstract - #305793
Title: Interval Estimation of Binomial Proportion in Clinical Trials with a Two-Stage Design
Author(s): Chen Chia Min*+
Companies: National Cheng Kung University
Address: , Tainan, 701,
Keywords: two-stage design ; Simon's two-stage design ; truncated binomial distribution ; coverage probability
Abstract:

A two-stage design is employed in Phase II clinical trials to avoid giving patients an ineffective drug. If the number of patients with significant improvement, which is a binomial response, is greater than a pre-specified value at the first stage then another binomial response at the second stage is also observed. This paper considers interval estimation of the response probability when the second stage is allowed to continue. Then the Wald, score, Clopper and Pearson, and Sterne intervals are constructed based on the two binomial responses from this two-stage design. The mean actual coverage probability and expected interval width are employed to evaluate the performance of these interval estimators. Comparison results recommend the use of score interval since its mean coverage probability is more close to the nominal confidence level than the other interval estimates investigated.

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