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},
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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