Journal
BIOMETRICS
Volume 79, Issue 3, Pages 1635-1645Publisher
WILEY
DOI: 10.1111/biom.13752
Keywords
clinical trial; competing risks; COVID-19; cumulative incidence; restricted mean time; weighted survival time
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This paper discusses the handling of competing risks data, particularly in clinical trials where multiple competing events may have different clinical interpretations. Estimation procedures and inferential properties are developed for the joint use of multiple cumulative incidence functions, and weighted CIFs and related metrics are considered by incorporating longitudinal marker information.
Competing risks data are commonly encountered in randomized clinical trials and observational studies. This paper considers the situation where the ending statuses of competing events have different clinical interpretations and/or are of simultaneous interest. In clinical trials, often more than one competing event has meaningful clinical interpretations even though the trial effects of different events could be different or even opposite to each other. In this paper, we develop estimation procedures and inferential properties for the joint use of multiple cumulative incidence functions (CIFs). Additionally, by incorporating longitudinal marker information, we develop estimation and inference procedures for weighted CIFs and related metrics. The proposed methods are applied to a COVID-19 in-patient treatment clinical trial, where the outcomes of COVID-19 hospitalization are either death or discharge from the hospital, two competing events with completely different clinical implications.
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