Non-inferiority trials with time-to-event data: clarifying the impact of censoring

Research output: Contribution to journalArticlepeer-review

Abstract

In non-inferiority (NI) trials with time-to-event data, different types and patterns of censoring may occur, but their impact on trial results is not entirely clear. We investigated the influence of informative and non-informative censoring by conducting extensive simulation studies under the assumption that the NI margin is defined as a maximum acceptable hazard ratio and scenarios typically observed in recent NI trials. We found that while non-informative censoring tends to only affect the power, informative censoring can impact the treatment effect estimates, type I error rate, and power. The magnitude of these effects depends on the between-group differences in the failure and informative censoring risks, as well as the correlation between censoring and failure times, among other factors. The adverse impact of informative censoring was generally decreased with larger NI margins.

Original languageEnglish (US)
Pages (from-to)222-239
Number of pages18
JournalJournal of Biopharmaceutical Statistics
Volume34
Issue number2
DOIs
StatePublished - 2024

Keywords

  • Cox proportional hazards model
  • Non-inferiority trials
  • informative censoring
  • time-to-event data

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

Fingerprint

Dive into the research topics of 'Non-inferiority trials with time-to-event data: clarifying the impact of censoring'. Together they form a unique fingerprint.

Cite this