What evidence do we need for biomarker qualification?

Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and acade...

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Bibliographic Details
Published in:Science translational medicine 2017-11, Vol.9 (417)
Main Authors: Leptak, Chris, Menetski, Joseph P, Wagner, John A, Aubrecht, Jiri, Brady, Linda, Brumfield, Martha, Chin, William W, Hoffmann, Steve, Kelloff, Gary, Lavezzari, Gabriela, Ranganathan, Rajesh, Sauer, John-Michael, Sistare, Frank D, Zabka, Tanja, Wholley, David
Format: Article
Language:English
Subjects:
Animals
Biomarkers
Humans
United States
United States Food and Drug Administration
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Summary:Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and academia that proposes a framework for defining the amount of evidence needed for biomarker qualification. This framework is intended for broad applications across multiple biomarker categories and uses.
ISSN:1946-6234
1946-6242
DOI:10.1126/scitranslmed.aal4599