FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019

Emerson Y Chen; Alyson Haslam; Vinay Prasad

doi:10.1001/jamainternmed.2020.1097

FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019

JAMA Intern Med. 2020 Jun 1;180(6):912-914. doi: 10.1001/jamainternmed.2020.1097.

Authors

Emerson Y Chen¹, Alyson Haslam¹, Vinay Prasad^{1

2}

Affiliations

¹ Knight Cancer Institute, Division of Hematology and Medical Oncology, Oregon Health & Science University, Portland.
² Department of Public Health and Preventive Medicine, Oregon Health & Science University, Portland.

Abstract

This retrospective review assesses the frequency of surrogate measures used for the first time vs subsequent times in a cancer setting and the surrogate’s strength of correlation with patient-centered outcomes.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antineoplastic Agents / pharmacokinetics*
Biomarkers, Tumor / metabolism*
Drug Approval / legislation & jurisprudence*
Humans
Neoplasms / drug therapy*
Neoplasms / metabolism
Retrospective Studies
United States
United States Food and Drug Administration*

Substances

Antineoplastic Agents
Biomarkers, Tumor