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EMA To See If Reviewing Patient-Level Data Can Speed Up Drug Evaluations

 
• By Vibha Sharma

A two-year pilot will explore the many potential benefits that the analysis of raw data can bring to the EU drug evaluation process. These range from faster patient access to medicines, companies facing fewer questions, and better definition of the target treatment population.

Doctor using laptop and electronic medical record (EMR) system. Digital database of patient's health care and personal information on computer screen.
EMA is legally allowed to ask for raw data from companies at any time to support drug assessments • Source: Shutterstock

The European Medicines Agency is launching a proof-of-concept pilot to explore whether it can speed up and improve its medicine evaluation process by reviewing individual patient-level data from clinical trials, which is also referred to as raw data.

The pilot is expected to start in September and will run for two years. During this time, companies can volunteer to submit raw data to the EMA as part of...

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