FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019
Author:
Affiliation:
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
Publisher
American Medical Association (AMA)
Subject
Internal Medicine
Link
https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/2764287/jamainternal_chen_2020_ld_200014.pdf
Reference6 articles.
1. Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: an analysis of 5 years of US Food and Drug Administration approvals.;Kim;JAMA Intern Med,2015
2. Strength of validation for surrogate end points used in the US Food and Drug Administration’s approval of oncology drugs.;Kim;Mayo Clin Proc,2016
3. Assessment of the clinical benefit of cancer drugs receiving accelerated approval.;Gyawali;JAMA Intern Med,2019
4. Estimation of study time reduction using surrogate end points rather than overall survival in oncology clinical trials.;Chen;JAMA Intern Med,2019
5. A systematic analysis of FDA-approved anticancer drugs.;Sun;BMC Syst Biol,2017
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