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

Journal of Law, Medicine and Ethics 47 (3):381-387 (2019)

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.

Download options

PhilArchive



    Upload a copy of this work     Papers currently archived: 72,805

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Analytics

Added to PP
2019-09-28

Downloads
4 (#1,287,712)

6 months
1 (#386,499)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Spencer Hey
Harvard University

References found in this work

No references found.

Add more references

Citations of this work

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

Add more citations

Similar books and articles

Toward a Jurisprudence of Drug Regulation.Matthew Herder - 2014 - Journal of Law, Medicine and Ethics 42 (2):244-262.
Race, Pharmacogenomics, and Marketing: Putting BiDil in Context.Jonathan Kahn - 2006 - American Journal of Bioethics 6 (5):W1-W5.
Analysis of Bioethical Problems Regarding Surrogate Conception in Japan.Masayuki Kodama - 2011 - Eubios Journal of Asian and International Bioethics 21 (1-2):34-36.
The Ethics of Commercial Surrogate Mothering: A Response to Casey Humbyrd.Peter Omonzejele - 2011 - Human Reproduction and Genetic Ethics 17 (1):110-121.
Drug Laws, Ethics, and History.Adam Greif - 2019 - Filozofia 74 (2):95 - 110.