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Sci Transl Med. 2017 Nov 22;9(417). pii: eaal4599. doi: 10.1126/scitranslmed.aal4599.

What evidence do we need for biomarker qualification?

Author information

1
Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
2
Foundation for the National Institutes of Health (NIH), North Bethesda, MD 20852, USA.
3
Takeda Pharmaceuticals International Co., Cambridge, MA 02139, USA.
4
Pfizer Inc., Groton, CT 06340, USA.
5
National Institute of Mental Health, NIH, Bethesda, MD 20892, USA.
6
Critical Path Institute, Tucson, AZ 85718, USA.
7
Pharmaceutical Research and Manufacturers of America, Washington, DC 20004, USA.
8
National Cancer Institute, NIH, Rockville, MD 20850, USA.
9
Biocerna LLC, Maple Lawn, MD 20759, USA.
10
Massachusetts General Hospital, Boston, MA 02114, USA.
11
Merck and Co. Inc., West Point, PA 19486, USA.
12
Genentech Inc., South San Francisco, CA 94080, USA.
13
Foundation for the National Institutes of Health (NIH), North Bethesda, MD 20852, USA. dwholley@fnih.org.

Abstract

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.

PMID:
29167393
DOI:
10.1126/scitranslmed.aal4599
[Indexed for MEDLINE]

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