Faculty, Staff and Student Publications

Publication Date

6-7-2024

Journal

JNCI: Journal of the National Cancer Institute

DOI

10.1093/jnci/djae028

PMID

38331394

PMCID

PMC12187001

PubMedCentral® Posted Date

2-9-2024

PubMedCentral® Full Text Version

Post-print

Abstract

Differential censoring, which refers to censoring imbalance between treatment arms, may bias the interpretation of survival outcomes in clinical trials. In 146 phase III oncology trials with statistically significant time-to-event surrogate primary endpoints, we evaluated the association between differential censoring in the surrogate primary endpoints, control arm adequacy, and the subsequent statistical significance of overall survival results. Twenty-four (16%) trials exhibited differential censoring that favored the control arm, whereas 15 (10%) exhibited differential censoring that favored the experimental arm. Positive overall survival was more common in control arm differential censoring trials (63%) than in trials without differential censoring (37%) or with experimental arm differential censoring (47%; odds ratio = 2.64, 95% confidence interval = 1.10 to 7.20; P = .04). Control arm differential censoring trials more frequently used suboptimal control arms at 46% compared with 20% without differential censoring and 13% with experimental arm differential censoring (odds ratio = 3.60, 95% confidence interval = 1.29 to 10.0; P = .007). The presence of control arm differential censoring in trials with surrogate primary endpoints, especially in those with overall survival conversion, may indicate an inadequate control arm and should be examined and explained.

Keywords

Humans, Neoplasms, Clinical Trials, Phase III as Topic, Research Design, Medical Oncology

Published Open-Access

yes

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