Which clinical trial designs and statistical approaches have been used in assessments of orphan maintenance by the European Medicines Agency between 2012 and 2022? A cross-sectional study.
Objectives In the European Union, a new orphan medicinal product must demonstrate ‘significant benefit’ over approved medicinal products targeting the same indication. To demonstrate a significant benefit, comparisons between the new product and the already approved medicinal products—either directl...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/12/e086171.full |
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