What evidence do we need for biomarker qualification?
生物标志物
医学
生物
遗传学
作者
Chris Leptak,Joseph P. Menetski,John A. Wagner,Jiri Aubrecht,Linda S. Brady,Martha A. Brumfield,William W. Chin,Steve Hoffmann,Gary J. Kelloff,Gabriela Lavezzari,Rajesh Ranganathan,John‐Michael Sauer,Frank D. Sistare,Tanja S. Zabka,David Wholley
出处
期刊:Science Translational Medicine [American Association for the Advancement of Science (AAAS)] 日期:2017-11-22卷期号:9 (417)被引量:57
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.