Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test.

@article{Kwak2014PhaseIC,
  title={Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test.},
  author={Minjung Kwak and Sin-Ho Jung},
  journal={Statistics in medicine},
  year={2014},
  volume={33 12},
  pages={2004-16}
}
Phase II clinical trials are often conducted to determine whether a new treatment is sufficiently promising to warrant a major controlled clinical evaluation against a standard therapy. We consider single-arm phase II clinical trials with right censored survival time responses where the ordinary one-sample logrank test is commonly used for testing the treatment efficacy. For planning such clinical trials, this paper presents two-stage designs that are optimal in the sense that the expected… CONTINUE READING

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