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Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders
INTRODUCTION: In rare diseases, registry-based studies can be used to provide natural history data pre-approval and complement drug efficacy and/or safety knowledge post-approval. OBJECTIVE: The objective of this study was to investigate the opinion of stakeholders about key aspects of rare disease...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8279983/ https://www.ncbi.nlm.nih.gov/pubmed/34091881 http://dx.doi.org/10.1007/s40264-021-01081-z |