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

Spencer Phillips Hey1, William B Feldman1, Emily H Jung1

  • 1Spencer 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.

The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics
|September 28, 2019
PubMed

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