The current practice for designing single-arm Phase II trials with time-to-event endpoints is limited to using either a maximum likelihood estimate test under the exponential model or a naive approach based on dichotomizing the event time at a landmark time point. A trial designed under the exponential model may not be reliable, and the naive approach is inefficient. The modified one-sample log-rank test statistic proposed in this article fills the void. In general, the proposed test can be used to design single-arm Phase II survival trials under any parametric survival distribution. Simulation results showed that it preserves type I error well and provides adequate power for Phase II cancer trial designs with time-to-event endpoints.
|Number of pages||13|
|Journal||Journal of Biopharmaceutical Statistics|
|State||Published - Jul 3 2016|
Bibliographical noteFunding Information:
This work was supported in part by the National Cancer Institute (NCI) support grant P30CA021765 and the American Lebanese Syrian Associated Charities (ALSAC).
© 2016 Taylor & Francis.
- Clinical trial design
- one-sample log-rank test
- sample size
- single-arm Phase II
- survival analysis
ASJC Scopus subject areas
- Statistics and Probability
- Pharmacology (medical)