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Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence. | LitMetric
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Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence.

Spencer Phillips Hey William B Feldman Emily H Jung Elvira D'Andrea Aaron S Kesselheim

J Law Med Ethics

Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School. William B. Feldman, M.D., D.Phil., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital. Emily H. Jung, A.B., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Elvira D'Andrea, M.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Aaron S. Kesselheim, M.D., J.D., M.P.H., Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Center for Bioethics, Harvard Medical School.

Published: September 2019

The FDA's new table of surrogate endpoints used for drug approvals is an important step forward for overseeing the use of biomarkers in clinical trials. Nevertheless, we present several ways in which the table can be improved.

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 Source
http://dx.doi.org/10.1177/1073110519876167DOI Listing

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