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Non-parametric group sequential designs in randomized clinical trials

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Summary

This paper examines some non-parametric group sequential designs applicable for randomized clinical trials, for comparing two continuous treatment effects taking the observations in matched pairs, or applicable in event-based analysis. Two inverse binomial sampling schemes are considered, of which the second one is an adaptive data-dependent design. These designs are compared with some fixed sample size competitors. Power and expected sample sizes are calculated for the proposed procedures.
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Keywords: equivalence; group sequential methods; inverse binomial sampling; repeated significance tests; stopping rule; type I error spending function

Document Type: Research Article

Affiliations: 1: University of Calcutta 2: Indian Statistical Institute

Publication date: September 1, 2003

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