Remodeling an existing rare disease registry to be used in regulatory context: Lessons learned and recommendations
Disease registries have been used as an interesting source of real-world data for supporting regulatory decision-making. In fact, drug studies based on registries cover pre-approval investigation, registry randomized clinical trials, and post-authorization studies. This opportunity has been investig...
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Main Authors: | Marina Mordenti (Author), Manila Boarini (Author), Fabio D'Alessandro (Author), Elena Pedrini (Author), Manuela Locatelli (Author), Luca Sangiorgi (Author) |
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Format: | Book |
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Frontiers Media S.A.,
2022-09-01T00:00:00Z.
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Online Access: | Connect to this object online. |
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