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Surrogate End Points Queried

Surrogate End Points Queried The Government Accountability Office (GAO) will review a drug approval process used by the Food and Drug Administration (FDA) that evaluates safety and efficacy based on surrogate end points in clinical trials. The review comes at the request of Sen Chuck Grassley (R, Iowa), who said March 4 that the FDA had approved several drugs that appeared to have little to no effect in protecting lives and improving health. Grassley singled out bevacizumab (Avastin, Genentech), rosiglitazone (Avandia, GlaxoSmithKline PLC), and ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough Pharmaceuticals). Grassley said the FDA had approved the drugs based on their effectiveness in achieving surrogate end point goals (such as limiting tumor growth) without determining whether the drugs improved health. The Iowa senator wants the GAO to analyze such issues as the number of drugs that were approved by the FDA based on surrogate end points, the surrogate end points used for approval, and whether the agency required companies to complete postmarketing trials to determine safety and efficacy. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Surrogate End Points Queried

JAMA , Volume 299 (14) – Apr 9, 2008

Surrogate End Points Queried

Abstract

The Government Accountability Office (GAO) will review a drug approval process used by the Food and Drug Administration (FDA) that evaluates safety and efficacy based on surrogate end points in clinical trials. The review comes at the request of Sen Chuck Grassley (R, Iowa), who said March 4 that the FDA had approved several drugs that appeared to have little to no effect in protecting lives and improving health. Grassley singled out bevacizumab (Avastin, Genentech), rosiglitazone (Avandia,...
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Publisher
American Medical Association
Copyright
Copyright © 2008 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.299.14.1657-a
Publisher site
See Article on Publisher Site

Abstract

The Government Accountability Office (GAO) will review a drug approval process used by the Food and Drug Administration (FDA) that evaluates safety and efficacy based on surrogate end points in clinical trials. The review comes at the request of Sen Chuck Grassley (R, Iowa), who said March 4 that the FDA had approved several drugs that appeared to have little to no effect in protecting lives and improving health. Grassley singled out bevacizumab (Avastin, Genentech), rosiglitazone (Avandia, GlaxoSmithKline PLC), and ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough Pharmaceuticals). Grassley said the FDA had approved the drugs based on their effectiveness in achieving surrogate end point goals (such as limiting tumor growth) without determining whether the drugs improved health. The Iowa senator wants the GAO to analyze such issues as the number of drugs that were approved by the FDA based on surrogate end points, the surrogate end points used for approval, and whether the agency required companies to complete postmarketing trials to determine safety and efficacy.

Journal

JAMAAmerican Medical Association

Published: Apr 9, 2008

Keywords: surrogate endpoints

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