EMA Outlines Use of Data Extrapolation in Pediatric Applications

October 18, 2017

The European Medicines Agency outlined its thoughts on the use of evidence generated through extrapolation techniques in regulatory assessments, in a draft reflection paper.

The paper aims to provide a framework for the quantitative methods needed to evaluate the relevance of existing clinical information in new, untested target populations, including pediatrics.

A specific extrapolation plan, the EMA said, can address the knowledge gaps inherent in making predictions for how a drug will perform in a new population — and can help allow the “totality of evidence” answer the scientific questions under a marketing authorization.

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