Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases

Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases

Abstract Background Previous evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA). Accepted standard endpoints for regulatory purposes are fr...

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Bibliographic Details
Main Authors: Thomas Staab, Georg Isbary, Volker E. Amelung, Jörg Ruof
Format: Article
Language:English
Published: BMC 2016-11-01
Series:BMC Health Services Research
Subjects:
Early benefit assessment
HTA
Marketing authorisation
Primary endpoint
AMNOG
Morbidity
Online Access:http://link.springer.com/article/10.1186/s12913-016-1902-8

Internet

http://link.springer.com/article/10.1186/s12913-016-1902-8

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