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In recent years, novel types of real‐world evidence (RWE) have played a role in various decision‐making processes relating to medicinal products, including regulatory approval, patient access, health technology assessment, safety… Click to show full abstract
In recent years, novel types of real‐world evidence (RWE) have played a role in various decision‐making processes relating to medicinal products, including regulatory approval, patient access, health technology assessment, safety monitoring, clinical use, and post‐approval lifecycle management. We therefore reviewed the potential utility of RWE in the cycle of medicinal product benefit‐risk (BR) assessment, communication/risk minimization and evaluation (“BRACE”).
Keywords:
real world;
world evidence;
risk;
risk assessment;
benefit risk;
assessment
Journal Title: Pharmacoepidemiology and Drug Safety
Year Published: 2020
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Journal Title: Pharmacoepidemiology and Drug Safety
Year Published: 2020
Link to full text (if available)
Share on Social Media: Sign Up to like & get
recommendations!