Reference curve sampling variability in one-sample log-rank tests.

ABSTRACT: The one-sample log-rank test is the method of choice for single-arm Phase II trials with time-to-event endpoint. It allows to compare the survival of patients to a reference survival curve that typically represents the expected survival under standard of care. The one-sample log-rank test, however, assumes that the reference survival curve is known. This ignores that the reference curve is commonly estimated from historic data and thus prone to sampling error. Ignoring sampling variability of the reference curve results in type I error rate inflation. We study this inflation in type I error rate analytically and by simulation. Moreover we derive the actual distribution of the one-sample log-rank test statistic, when the sampling variability of the reference curve is taken into account. In

SUBMITTER: Danzer MF 

PROVIDER: S-EPMC9302761 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature