The European Medicines Agency (EMA) has published a draft reflection paper titled Extrapolation of efficacy and safety in pediatric medicine development. According to the EMA this paper “outlines a systematic approach to extrapolation of data from adults or other pediatric populations to children that is considered scientifically sound and reliable to support the authorization of a medicine (and) when, to what extent, and how extrapolation can be applied and validated.”
The document explains the principles steps taken to ensure that extrapolation to pediatric population is reliable and valid. The framework illustrates the rationale for extrapolation, how the concept for extrapolation can be defined. It then describes how a plan can be made based on the concept and finally methods to analyze the efficacy of the extrapolation. The framework also details the uncertainty and risk during extrapolating data from adults to children can be dealt with, as well as how extrapolation can be applied through the life cycle of product development.
EMA is organizing a workshop on 17-18 May 2016 to gather the views from experts and stakeholders on the topic. These discussions will contribute to the further development of the draft refection paper which will released for public consultation.
EMA will also hold the 8th annual workshop on 2 June 2016 to promote high-quality clinical research to develop more and better medicines for children. This workshops is organized by the European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA)