Sample size calculation for small sample single-arm trials for time-to-event data: Logrank test with normal approximation or test statistic based on exact chi-square distribution?

ABSTRACT:

Background

Sample size calculations are critical to the planning of a clinical trial. For single-arm trials with time-to-event endpoint, standard software provides only limited options. The most popular option is the log-rank test. A second option assuming exponential distribution is available on some online websites. Both these approaches rely on asymptotic normality for the test statistic and perform well for moderate-to-large sample sizes.

Methods

As many new treatments in the field of oncology are cost-prohibitive and have slow accrual rates, researchers are often faced with the restriction of conducting single arm trials with potentially small-to-moderate sample sizes. As a practical solution, therefore, we consider the option of performing the sample size calculations

SUBMITTER: Phadnis MA 

PROVIDER: S-EPMC6500916 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature