Adaptive Licensing and Conditional Approval: A Perspective on Evidence Owed After Market Entry
DOI:
https://doi.org/10.5281/zenodo.22649112Keywords:
Adaptive Licensing and Conditional Approval; Translational medicine;, Evidence synthesis; Clinical implementation; Health services researchAbstract
Adaptive Licensing and Conditional Approval is an area of active development in translational medicine, with evidence that has
accumulated unevenly across its component questions. We review the current evidence base for adaptive licensing and conditional
approval, spanning analytical, clinical, implementation, governance, and economic dimensions, focusing on where practice has
converged and where it continues to vary, and set out the practical considerations relevant to a service considering its adoption.
We conclude that selective, context-specific use is best supported by the evidence currently available, rather than uniform
adoption or avoidance.
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