Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: A report from the Cardiac Safety Research Consortium

This white paper provides a summary of presentations and discussions at a cardiovascular (CV) end point adjudication think tank cosponsored by the Cardiac Safety Research Committee and the US Food and Drug Administration (FDA) that was convened at the FDA's White Oak headquarters on November 6,...

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Veröffentlicht in:	The American heart journal 2015-02, Vol.169 (2), p.197-204
Hauptverfasser:	Seltzer, Jonathan H., MD, MBA, MA, Turner, J. Rick, PhD, Geiger, Mary Jane, MD, PhD, Rosano, Giuseppe, MD, PhD, Mahaffey, Kenneth W., MD, White, William B., MD, Sabol, Mary Beth, MD, Stockbridge, Norman, MD, PhD, Sager, Philip T., MD
Format:	Artikel
Sprache:	eng
Schlagworte:	Benchmarking Cardiology - methods Cardiology - standards Cardiovascular Cardiovascular Diseases - drug therapy Clinical trials Clinical Trials as Topic - methods Clinical Trials as Topic - standards Clinical Trials Data Monitoring Committees Critical path Drug therapy Endpoint Determination - methods Endpoint Determination - standards Experts Heart attacks Heart failure Hospitalization Humans Hypertension Pharmaceutical industry Pharmacological Phenomena Quality control Research Design Safety Management United States United States Food and Drug Administration
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