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J Law Med Ethics. 2019 Sep;47(3):357-361. doi: 10.1177/1073110519876162.

Challenges and Opportunities for Biomarker Validation.

Author information

1
Spencer Phillips Hey, Ph.D., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. He is also affiliated with the Center for Bioethics at Harvard Medical School. Elvira D'Andrea, M.D., M.P.H., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. Emily H. Jung, A.B., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. Frazer Tessema, B.A., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. Jing Luo, M.D., M.P.H., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. Bishal Gyawali, M.D., Ph.D., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. Aaron S. Kesselheim, M.D., J.D., M.P.H., is at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, at Harvard Medical School, in Boston, Massachusetts. He is also affiliated with the Center for Bioethics at Harvard Medical School, and serves as the Edited-in-Chief of the Journal of Law, Medicine & Ethics.

Abstract

Biomarkers can be powerful tools to guide diagnosis, treatment, and research. However, prudent use of bio-markers requires formal validation efforts. Although the data needed for biomarker validation has traditionally been hard to access, new research initiatives can ease this process.

PMID:
31560620
DOI:
10.1177/1073110519876162

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