Challenges and Opportunities for Biomarker Validation

Spencer Phillips Hey¹, Elvira D'Andrea¹, Emily H Jung¹, Frazer Tessema¹, Jing Luo¹, Bishal Gyawali¹, Aaron S Kesselheim¹

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Affiliation

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.

PMID: 31560620
DOI: 10.1177/1073110519876162

Challenges and Opportunities for Biomarker Validation

Spencer Phillips Hey et al. J Law Med Ethics. 2019 Sep.

. 2019 Sep;47(3):357-361.

doi: 10.1177/1073110519876162.

Authors

Spencer Phillips Hey¹, Elvira D'Andrea¹, Emily H Jung¹, Frazer Tessema¹, Jing Luo¹, Bishal Gyawali¹, Aaron S Kesselheim¹

Affiliation

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.

PMID: 31560620
DOI: 10.1177/1073110519876162

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.

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Challenges and Opportunities for Biomarker Validation

Affiliation

Challenges and Opportunities for Biomarker Validation

Authors

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Abstract

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