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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| Main Authors: | , , , |
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| Format: | Book |
| Published: |
BMC,
2016-11-01T00:00:00Z.
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| Subjects: | |
| Online Access: | Connect to this object online. |
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