Adjusting for misclassification in a stratified biomarker clinical trial

Chunling Liu, Aiyi Liu, Jiang Hu, Vivian Yuan, Susan Halabi

Research output: Journal article publicationJournal articleAcademic researchpeer-review

15 Citations (Scopus)


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.
Original languageEnglish
Pages (from-to)3100-3113
Number of pages14
JournalStatistics in Medicine
Issue number18
Publication statusPublished - 15 Aug 2014


  • Biomarkers
  • Classification error
  • Correction for error
  • Personalized medicine
  • Power and sample size
  • Prevalence
  • Randomized controlled clinical trials
  • Sensitivity and specificity

ASJC Scopus subject areas

  • Epidemiology
  • Statistics and Probability


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