Pivotal Evaluation of the Accuracy of a Biomarker Used for Classification or Prediction: Standards for Study Design
Fred Hutch Cancer Center · Academic Medical Center
Abstract
Research methods for biomarker evaluation lag behind those for evaluating therapeutic treatments. Although a phased approach to development of biomarkers exists and guidelines are available for reporting study results, a coherent and comprehensive set of guidelines for study design has not been delineated. We describe a nested case-control study design that involves prospective collection of specimens before outcome ascertainment from a study cohort that is relevant to the clinical application. The biomarker is assayed in a blinded fashion on specimens from randomly selected case patients and control subjects in the study cohort. We separately describe aspects of the design that relate to the clinical context,…
Citation impact
- FWCI
- 37.76
- Percentile
- 100%
- References
- 30
Authors
5- MSMargaret S. PepeCorresponding
Fred Hutch Cancer Center, Academic Medical Center
- ZFZiding Feng
Academic Medical Center, Fred Hutch Cancer Center
- HJHolly Janes
Academic Medical Center, Fred Hutch Cancer Center
- PMPatrick M. Bossuyt
Academic Medical Center, Fred Hutch Cancer Center
- JDJohn D. Potter
Academic Medical Center, Fred Hutch Cancer Center
Topics & keywords
- Computer science
- Biomarker
- Machine learning
- Artificial intelligence
- Data mining
- Biology