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A comparison of different population-level summary measures for randomised trials with time-to-event outcomes, with a focus on non-inferiority trials.

Matteo QuartagnoTim P MorrisDuncan C GilbertRuth E LangleyMatthew G NankivellMahesh Kb ParmarIan R White
Published in: Clinical trials (London, England) (2023)
When the hazards are likely to be approximately proportional, reflecting this in the analysis can lead to large gains in power for difference in restricted mean survival time and difference in survival. The choice of summary measure for a non-inferiority trial with time-to-event outcomes should be made on clinical grounds; when any of the three summary measures discussed here is equally justifiable, difference in restricted mean survival time is most often associated with the most powerful test, on the condition that it is estimated under proportional hazards.
Keyphrases
  • clinical trial
  • free survival
  • study protocol
  • metabolic syndrome
  • type diabetes
  • skeletal muscle
  • randomized controlled trial
  • placebo controlled
  • adipose tissue