Time to Review the Role of Surrogate End Points in Health Policy: State of the Art and the Way Forward

The efficacy of medicines, medical devices, and other health technologies should be proved in trials that assess final patient-relevant outcomes such as survival or morbidity. Market access and coverage decisions are, however, often based on surrogate end points, biomarkers, or intermediate end poin...

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Veröffentlicht in:	Value in health Jg. 20; H. 3; S. 487 - 495
Hauptverfasser:	Ciani, Oriana, Buyse, Marc, Drummond, Michael, Rasi, Guido, Saad, Everardo D., Taylor, Rod S.
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States Elsevier Inc 01.03.2017 Elsevier Science Ltd
Schlagworte:	Adoption of innovations Biological markers Biomarkers clinical outcome assessment Clinical outcomes Clinical research Clinical trials Clinical Trials as Topic Disease-Free Survival Drugs Efficacy Evidence-Based Medicine Health care policy Health Policy Health services health technology assessment Humans Internal Medicine Medical equipment Medical Oncology Medical supplies Medical technology Morbidity Patient communication Patients Policy making Quality-Adjusted Life Years surrogate end points Technology Assessment, Biomedical Treatment Outcome United States United States Food and Drug Administration validation Validity health technology assessment clinical outcome assessment surrogate end points validation
ISSN:	1098-3015, 1524-4733, 1524-4733
Online-Zugang:	Volltext
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