Are Surrogate Markers Adequate to Assess Cardiovascular Disease Drugs?

The use of surrogate end points as a basis for conclusions about therapy and drugs for cardiovascular disease is both praised and criticized as it has resulted in both successes and failures. Surrogate end points can lead to much faster approval of drugs, but the consequences of relying on such data...

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Veröffentlicht in:	JAMA : the journal of the American Medical Association 1999-08, Vol.282 (8), p.790-795
1. Verfasser:	Temple, Robert
Format:	Artikel
Sprache:	eng
Schlagworte:	Biomarkers Cardiovascular Agents - therapeutic use Cardiovascular disease Cardiovascular Diseases - prevention & control Clinical trials Clinical Trials as Topic Drug Approval Drug Evaluation FDA approval Humans Medical research Pharmaceuticals Risk Treatment Outcome United States United States Food and Drug Administration
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Beschreibung
Zusammenfassung:	The use of surrogate end points as a basis for conclusions about therapy and drugs for cardiovascular disease is both praised and criticized as it has resulted in both successes and failures. Surrogate end points can lead to much faster approval of drugs, but the consequences of relying on such data must be carefully weighed.
ISSN:	0098-7484 1538-3598
DOI:	10.1001/jama.282.8.790