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Wiley, Statistics in Medicine, 17(33), p. 2897-2913, 2014

DOI: 10.1002/sim.6154

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Sample size determination in group-sequential clinical trials with two co-primary endpoints

Journal article published in 2014 by Koko Asakura, Toshimitsu Hamasaki ORCID, Tomoyuki Sugimoto, Kenichi Hayashi, Scott R. Evans, Takashi Sozu
This paper is available in a repository.
This paper is available in a repository.

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Abstract

We discuss sample size determination in group-sequential designs with two endpoints as co-primary. We derive the power and sample size within two decision-making frameworks. One is to claim the test intervention’s benefit relative to control when superiority is achieved for the two endpoints at the same interim timepoint of the trial. The other is when the superiority is achieved for the two endpoints at any interim timepoint, not necessarily simultaneously. We evaluate the behaviors of sample size and power with varying design elements and provide a real example to illustrate the proposed sample size methods. In addition, we discuss sample size recalculation based on observed data and evaluate the impact on the power and Type I error rate.