What evidence do we need for biomarker qualification?

Science Translational Medicine
22 November 2017  Vol 9, Issue 417

What evidence do we need for biomarker qualification?
By Chris Leptak, Joseph P. Menetski, John A. Wagner, Jiri Aubrecht, Linda Brady, Martha Brumfield, William W. Chin, Steve Hoffmann, Gary Kelloff, Gabriela Lavezzari, Rajesh Ranganathan, John-Michael Sauer, Frank D. Sistare, Tanja Zabka, David Wholley
Science Translational Medicine22 Nov 2017 Restricted Access
Predictable steps are needed to determine the evidence required for confident use of a biomarker in drug development.
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.