What evidence do we need for biomarker qualification?-Reference-Cited by-同舟云学术

What evidence do we need for biomarker qualification?

Published:2017-11-22 Issue:417 Volume:9 Page:
ISSN:1946-6234
Container-title:Science Translational Medicine
language:en
Short-container-title:Sci. Transl. Med.

Author:

Leptak Chris¹^ORCID,Menetski Joseph P.²^ORCID,Wagner John A.³,Aubrecht Jiri⁴^ORCID,Brady Linda⁵^ORCID,Brumfield Martha⁶,Chin William W.⁷,Hoffmann Steve²^ORCID,Kelloff Gary⁸,Lavezzari Gabriela⁹,Ranganathan Rajesh¹⁰,Sauer John-Michael⁶,Sistare Frank D.¹¹^ORCID,Zabka Tanja¹²,Wholley David²^ORCID

Affiliation:

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.

Abstract

Predictable steps are needed to determine the evidence required for confident use of a biomarker in drug development.

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

Reference21 articles.

1. A. Sertkaya A. Birkenbach B. A. J. Eyraud “Examination of Clinical Trial Costs and Barriers for Drug Development” (2014); http://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development.

2. FDA-NIH Biomarker Working Group BEST (Biomarkers EndpointS and other Tools) Resource (Food and Drug Administration and National Institutes of Health 2016).

3. The 6-Minute-Walk Distance Test as a Chronic Obstructive Pulmonary Disease Stratification Tool. Insights from the COPD Biomarker Qualification Consortium

4. Biomarkers and personalized medicine: current status and further perspectives with special focus on dermatology

5. Industry perspectives on biomarker qualification

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