EMA Outlines Use of Data Extrapolation in Pediatric Applications

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.