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Real-World Evidence: ‘Labor-Intensive’ Data Standardization May Be Required By US FDA

 
• By Derrick Gingery

New draft guidance offers recommendations for translating real-world data from claims or EHR sources to meet FDA data requirements.

caduceus on binary background (Alamy)
Because real-world data comes from different sources, terminology and other items have to be standardized in order to be analyzed. • Source: Alamy

Standardizing real-world data to fit US Food and Drug Administration requirements can be difficult, and new guidance suggests a less-labor intensive solution may not be ideal when the information is intended to show safety or efficacy.

Since claims, electronic health record and other real-world data often are formatted differently than the agency requires, FDA expects sponsors to make the necessary adjustments to ensure it can be...

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