Open AccessAn audit strategy for time-to-event outcomes measured with error: Application to five randomized controlled trials in oncology
Author(s) -
Lori E. Dodd,
Edward L. Korn,
Boris Freidlin,
Wenjuan Gu,
Jeffrey S. Abrams,
William D. Bushnell,
Renzo Canetta,
James H. Doroshow,
Robert J. Gray,
Rajeshwari Sridhara
Publication year - 2013
Publication title -
clinical trials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.559
H-Index - 63
eISSN - 1740-7753
pISSN - 1740-7745
DOI - 10.1177/1740774513493973
Subject(s) - sample size determination , randomized controlled trial , estimator , medicine , event (particle physics) , audit , clinical trial , statistics , medical physics , mathematics , accounting , physics , quantum mechanics , business
Measurement error in time-to-event end points complicates interpretation of treatment effects in clinical trials. Non-differential measurement error is unlikely to produce large bias [1]. When error depends on treatment arm, bias is of greater concern. Blinded-independent central review (BICR) of all images from a trial is commonly undertaken to mitigate differential measurement-error bias that may be present in hazard ratios (HRs) based on local evaluations. Similar BICR and local evaluation HRs may provide reassurance about the treatment effect, but BICR adds considerable time and expense to trials.