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EMA Takes A Dive Into Patient-Level Data

 
• By Vibha Sharma

The European Medicines Agency will begin a pilot in 2021 to examine the practical aspects of undertaking patient-level data assessments during medicines evaluation and identify scenarios when such assessments might be useful.

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EMA Had Requested Patient-Level Data While Reviewing Yescarta • Source: Shutterstock

The exponential growth of big data and the need for new analytic techniques to go with it have made it important for the European Medicines Agency to have a clear stand on whether individual patient-level data (PLD) should be routinely assessed as part of the EU marketing authorization procedure.

To address the issue, the EMA is gearing up to undertake a broad review of the experience gained so far by its various scientific committees in reviewing PLD, Peter Arlett...

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