Please use this identifier to cite or link to this item: http://hdl.handle.net/10397/36285
Title: Adjusting for misclassification in a stratified biomarker clinical trial
Authors: Liu, CL 
Liu, AY
Hu, J
Yuan, VVA
Halabi, S
Keywords: Biomarkers
Classification error
Correction for error
Personalized medicine
Power and sample size
Prevalence
Randomized controlled clinical trials
Sensitivity and specificity
Issue Date: 2014
Publisher: John Wiley & Sons
Source: Statistics in medicine, 2014, v. 33, no. 18, p. 3100-3113 How to cite?
Journal: Statistics in medicine 
Abstract: Clinical trials utilizing predictive biomarkers have become a research focus in personalized medicine. We investigate the effects of biomarker misclassification on the design and analysis of stratified biomarker clinical trials. For a variety of inference problems including marker-treatment interaction in particular, we show that marker misclassification may have profound adverse effects on the coverage of confidence intervals, power of the tests, and required sample sizes. For each inferential problem, we propose methods to adjust for the classification errors.
URI: http://hdl.handle.net/10397/36285
ISSN: 0277-6715 (print)
1097-0258 (online)
DOI: 10.1002/sim.6164
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