Conditional estimation of sensitivity and specificity from a phase 2 biomarker study allowing early termination for futility.

@article{Pepe2009ConditionalEO,
  title={Conditional estimation of sensitivity and specificity from a phase 2 biomarker study allowing early termination for futility.},
  author={Margaret Sullivan Pepe and Ziding Feng and Gary M. Longton and Joseph Koopmeiners},
  journal={Statistics in medicine},
  year={2009},
  volume={28 5},
  pages={762-79}
}
Development of a disease screening biomarker involves several phases. In phase 2 its sensitivity and specificity is compared with established thresholds for minimally acceptable performance. Since we anticipate that most candidate markers will not prove to be useful and availability of specimens and funding is limited, early termination of a study is appropriate, if accumulating data indicate that the marker is inadequate. Yet, for markers that complete phase 2, we seek estimates of sensitivity… CONTINUE READING