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On permutation tests for comparing restricted mean survival time with small sample from randomized trials.

Miki Horiguchi1,2, Hajime Uno1,2,3

  • 1Department of Medical Oncology, Division of Population Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

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Summary

Restricted mean survival time (RMST) comparisons in randomized controlled trials (RCTs) using permutation tests are reliable for small sample sizes. These permutation methods effectively address numerical issues and maintain acceptable type I error rates, unlike asymptotic tests.

Keywords:
randomization testrandomized clinical trialssurvival analysistime-to-event outcomestype I error rate

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Area of Science:

  • Biostatistics
  • Clinical Trials
  • Survival Analysis

Background:

  • Restricted mean survival time (RMST) is an emerging metric for time-to-event outcomes in randomized controlled trials (RCTs).
  • Conventional logrank/hazard ratio methods may be unreliable with small sample sizes, where large sample theories do not apply.
  • Permutation approaches are generally suitable for small sample scenarios but face numerical challenges with RMST comparisons.

Purpose of the Study:

  • To investigate a numerical issue in permutation tests for comparing restricted mean survival time (RMST) between two groups in RCTs.
  • To evaluate the performance of six permutation methods for RMST comparison in small sample settings.
  • To compare the type I error rates of permutation tests against asymptotic methods for RMST analysis.

Main Methods:

  • Considered six distinct permutation methods for comparing survival distributions using RMST.
  • Conducted extensive numerical simulations to assess the performance of these methods.
  • Evaluated type I error rates under small sample conditions.

Main Results:

  • Asymptotic methods showed non-negligible inflation of type I error rates with small sample sizes.
  • All six permutation methods proved to be workable solutions for RMST comparison.
  • Permutation tests exhibited conservative tendencies but maintained acceptable type I error rates, avoiding significant inflation.

Conclusions:

  • Permutation tests are recommended over asymptotic tests for RMST comparisons in RCTs, particularly when sample sizes are small (e.g., <50 per arm).
  • Permutation methods provide a robust alternative for survival analysis in challenging small sample trial designs.