Conditional estimation after a two-stage diagnostic biomarker study that allows early termination for futility

Joseph S. Koopmeiners, Ziding Feng, Margaret Sullivan Pepe

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

Abstract

Many biomarkers identified in marker discovery are shown to have inadequate performance in validation studies. This motivates the use of group sequential designs that allow early termination for futility. However, an option for early termination will lead to biased estimates for studies that reach full enrollment. We propose conditional estimators and confidence intervals that correct for this bias assuming that an unadjusted estimator exists that has an independent increments covariance structure. The proposed estimators and confidence intervals are applied to conditional estimation of the receiver operating characteristic curve and the positive predictive value curve after a two-stage study that allows early termination for futility, and their performance is evaluated by simulation.

Original languageEnglish (US)
Pages (from-to)420-435
Number of pages16
JournalStatistics in Medicine
Volume31
Issue number5
DOIs
StatePublished - Feb 28 2012

Keywords

  • Conditional estimation
  • Diagnostic biomarkers, group sequential design
  • PPV curve
  • ROC curve

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