EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation

 
• By Vibha Sharma

Early results from an ongoing EU pilot on the use of clinical trial raw data in medicines evaluation have pointed to many benefits. These include fewer questions for companies and greater clarity for regulators on information submitted in marketing authorization dossiers.

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Access to clinical trial raw data can help regulators better understand the evidence submitted in marketing applications • Source: Shutterstock

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