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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

The interim results of an ongoing pilot at the European Medicines Agency indicate that using individual patient-level data from clinical trials (also called raw data) in regulatory procedures for initial marketing authorization applications (MAAs) and post-authorization applications can enhance the evaluation process.

Key Takeaways

  • After an EU proof-of-concept pilot investigating the benefits of visualizing and analyzing clinical trial raw data to support the scientific assessment of medicinal products reached its mid-way point in December 2023, surveys were conducted with pilot participants.

There are “clear early signals confirming the added value of regulatory access to raw data in support of the regulatory...

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