Sample size calculations for single‐arm survival studies using transformations of the Kaplan–Meier estimator

  title={Sample size calculations for single‐arm survival studies using transformations of the Kaplan–Meier estimator},
  author={Kengo Nagashima and Hisashi Noma and Yasunori Sato and Masahiko Gosho},
  journal={Pharmaceutical Statistics},
  pages={499 - 511}
In single‐arm clinical trials with survival outcomes, the Kaplan–Meier estimator and its confidence interval are widely used to assess survival probability and median survival time. Since the asymptotic normality of the Kaplan–Meier estimator is a common result, the sample size calculation methods have not been studied in depth. An existing sample size calculation method is founded on the asymptotic normality of the Kaplan–Meier estimator using the log transformation. However, the small sample… 
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