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The role of statistics in the design and analysis of companion diagnostic (CDx) studies

The role of statistics in the design and analysis of companion diagnostic (CDx) studies Companion diagnostic tests are crucial in the development of precision medicine. These tests provide information that is essential for the safe and effective use of specific therapeutic products. Statistics plays a key role in the design and analysis of studies to demonstrate the safety and effectiveness of the companion diagnostics. This article can serve as an introduction to companion diagnostics for therapeutic statisticians and for diagnostic ones as well as a discussion of some of the statistical challenges. The topics include biomarker development, diagnostic performance, misclassification, prospective-retrospective validation, bridging studies, missing data, follow-on diagnostics and complex signatures. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Biostatistics & Epidemiology Taylor & Francis

The role of statistics in the design and analysis of companion diagnostic (CDx) studies

Biostatistics & Epidemiology , Volume 5 (2): 14 – Jul 3, 2021

The role of statistics in the design and analysis of companion diagnostic (CDx) studies

Abstract

Companion diagnostic tests are crucial in the development of precision medicine. These tests provide information that is essential for the safe and effective use of specific therapeutic products. Statistics plays a key role in the design and analysis of studies to demonstrate the safety and effectiveness of the companion diagnostics. This article can serve as an introduction to companion diagnostics for therapeutic statisticians and for diagnostic ones as well as a discussion of some of the...
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Publisher
Taylor & Francis
Copyright
© 2021 International Biometric Society – Chinese Region
ISSN
2470-9379
eISSN
2470-9360
DOI
10.1080/24709360.2021.1913706
Publisher site
See Article on Publisher Site

Abstract

Companion diagnostic tests are crucial in the development of precision medicine. These tests provide information that is essential for the safe and effective use of specific therapeutic products. Statistics plays a key role in the design and analysis of studies to demonstrate the safety and effectiveness of the companion diagnostics. This article can serve as an introduction to companion diagnostics for therapeutic statisticians and for diagnostic ones as well as a discussion of some of the statistical challenges. The topics include biomarker development, diagnostic performance, misclassification, prospective-retrospective validation, bridging studies, missing data, follow-on diagnostics and complex signatures.

Journal

Biostatistics & EpidemiologyTaylor & Francis

Published: Jul 3, 2021

Keywords: Co-development; predictive biomarker; diagnostic performance; bridging studies; complex signatures

References