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A class of confidence intervals for sequential phase II clinical trials with binary outcome

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The phase II clinical trials often use the binary outcome. Thus, accessing the success rate of the treatment is a primary objective for the phase II clinical trials. Reporting confidence intervals is a common practice for clinical trials. Due to the group sequence design and relatively small sample size, many existing confidence intervals for phase II trials are much conservative. In this paper, we propose a class of confidence intervals for binary outcomes. We also provide a general theory to assess the coverage of confidence intervals for discrete distributions, and hence make recommendations for choosing the parameter in calculating the confidence interval. The proposed method is applied to Simon's [14] optimal two-stage design with numerical studies. The proposed method can be viewed as an alternative approach for the confidence interval for discrete distributions in general.
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Keywords: Simon's optimal design; binomial parameter; coverage probability; discrete distribution; expected length; two-stage design

Document Type: Research Article

Affiliations: Department of Biostatistics, University of North Texas Health Science Center, Fort Worth, TX, USA

Publication date: March 1, 2011

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