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

Journal of Law, Medicine and Ethics 47 (3):381-387 (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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Spencer Hey
Harvard University

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Citations of this work

Biomarker Validation: Context and Complexities.Lisa M. McShane - 2019 - Journal of Law, Medicine and Ethics 47 (3):388-392.

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