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Piloting Real-World Evidence: US FDA RWE Demonstration Projects

 
• By Bridget Silverman

Agency offers three informal ‘buckets’ organized around data, study design and tools.

RWE pilot
• Source: Shutterstock

Kenneth Quinto, CDER Office of Medical Policy senior medical advisor for RWE analytics, provided an update on demonstration projects funded by the FDA under the RWE Framework at the Drug Information Association meeting in San Diego, Calif. earlier this month. Consistent with past Office of Medical Policy communications, Quinto classified the RWE demonstration projects in three informal “buckets” organized around data, study design and tools.

Quinto identified quality, relevance and linkage of data as key themes for the FDA’s demonstration projects.

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