Adjusting for misclassification in a stratified biomarker clinical trial.
Journal Article (Journal Article)
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.
Full Text
Duke Authors
Cited Authors
- Liu, C; Liu, A; Hu, J; Yuan, V; Halabi, S
Published Date
- August 15, 2014
Published In
Volume / Issue
- 33 / 18
Start / End Page
- 3100 - 3113
PubMed ID
- 24733510
Pubmed Central ID
- 24733510
Electronic International Standard Serial Number (EISSN)
- 1097-0258
Digital Object Identifier (DOI)
- 10.1002/sim.6164
Language
- eng
Conference Location
- England