What evidence do we need for biomarker qualification?

Affiliations

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.

PMID: 29167393
DOI: 10.1126/scitranslmed.aal4599

Review

What evidence do we need for biomarker qualification?

Chris Leptak et al. Sci Transl Med. 2017.

. 2017 Nov 22;9(417):eaal4599.

doi: 10.1126/scitranslmed.aal4599.

Authors

Affiliations

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.

PMID: 29167393
DOI: 10.1126/scitranslmed.aal4599

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.

PubMed Disclaimer

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions

Substances

Actions

LinkOut - more resources

Full Text Sources
- Atypon
Other Literature Sources
- scite Smart Citations

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

What evidence do we need for biomarker qualification?

Affiliations

What evidence do we need for biomarker qualification?

Authors

Affiliations

Abstract

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Other Literature Sources