Duffy-Santner Confidence Intervals for the Two-Stage Three-Outcome Design

Although the three-outcome phase II clinical trial design (Sargent et al., 2001 ) has seen increasing use, confidence interval methodology for the binary endpoint had not been explicitly defined. Typical phase II clinical trial designs with binomial endpoints use a sequential binomial confidence int...

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Bibliographic Details
Published in:Journal of biopharmaceutical statistics 2006-12, Vol.16 (6), p.875-880
Main Authors: Furth, Alfred F., Sargent, Daniel J.
Format: Article
Language:English
Subjects:
Computer Simulation
Confidence interval
Confidence Intervals
Linear Models
Phase II design
Research Design - statistics & numerical data
Three-outcome
Treatment Outcome
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Summary:Although the three-outcome phase II clinical trial design (Sargent et al., 2001 ) has seen increasing use, confidence interval methodology for the binary endpoint had not been explicitly defined. Typical phase II clinical trial designs with binomial endpoints use a sequential binomial confidence interval (SBCI) algorithm (Duffy and Santner, 1987 ). We reviewed the SBCI literature and software in order to describe the construction of confidence intervals for the three-outcome setting. Simulations confirmed that proper application of the SBCI algorithm provides appropriate coverage for the three-outcome design.
ISSN:1054-3406
1520-5711
DOI:10.1080/10543400600825710