EMA To See If Reviewing Patient-Level Data Can Speed Up Drug Evaluations
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.
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The EU’s big data steering group has laid out some ambitious proposals for integrating real-world evidence into regulatory decision making, as well as plans for ongoing engagement on the use and analysis of RWE with industry and other stakeholders.
A panel of regulators overseeing the implementation of several big data projects within the EU medicines network has given details of real-world evidence integration pilots to be undertaken next year by various European Medicines Agency scientific committees.
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.