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

@article{Asakura2014SampleSD,
  title={Sample size determination in group-sequential clinical trials with two co-primary endpoints.},
  author={Koko Asakura and Toshimitsu Hamasaki and Tomoyuki Sugimoto and Kenichi Hayashi and Scott R. Evans and Takashi Sozu},
  journal={Statistics in medicine},
  year={2014},
  volume={33 17},
  pages={2897-913}
}
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 superiority is achieved for the two endpoints at any interim timepoint, not necessarily simultaneously. We evaluate the behaviors of sample size… CONTINUE READING
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