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

Published online by Cambridge University Press:  01 January 2021

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

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.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 3: Biomarker Research and Validation: Current Challenges, Future Opportunities , Fall 2019 , pp. 381 - 387
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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