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
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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.
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Feedback shows there are clear early signals confirming the added value of regulatory access to raw data in support of the regulatory assessment.
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While the US FDA Administration routinely asks for raw data as part of its assessment process, EU regulators only request for such data on an ad hoc basis, when necessary.
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The pilot confirmed that the use of data packages requirements by other international regulators are suitable for use by EU regulators
There are “clear early signals confirming the added value of regulatory access to raw data in support of the regulatory assessment” process, the EMA
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