Comparison of Time-to-First Event and Recurrent-Event Methods in Randomized Clinical Trials
Author(s) -
Brian Claggett,
Stuart J. Pocock,
L. J. Wei,
Marc A. Pfeffer,
John J.V. McMurray,
Scott D. Solomon
Publication year - 2018
Publication title -
circulation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 7.795
H-Index - 607
eISSN - 1524-4539
pISSN - 0009-7322
DOI - 10.1161/circulationaha.117.033065
Subject(s) - medicine , discontinuation , randomization , relative risk , randomized controlled trial , proportional hazards model , confidence interval , clinical trial , placebo , event (particle physics) , absolute risk reduction , statistics , mathematics , physics , quantum mechanics , alternative medicine , pathology
Most phase-3 trials feature time-to-first event end points for their primary and secondary analyses. In chronic diseases, where a clinical event can occur >1 time, recurrent-event methods have been proposed to more fully capture disease burden and have been assumed to improve statistical precision and power compared with conventional time-to-first methods.
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