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

  • PMC4107031

Electronic International Standard Serial Number (EISSN)

  • 1097-0258

Digital Object Identifier (DOI)

  • 10.1002/sim.6164


  • eng

Conference Location

  • England