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Drug watchdog: ‘Adult data can be used for children’s medicines’
by Gary Finnegan: The European Medicines Agency (EMA) has published a draft version of a new paper on how to extrapolate clinical trial data from adults to children. The framework is designed to facilitate the authorisation of new medicines for children using robust extrapolation techniques.
The EU’s Paediatric Regulation aims to optimise the involvement of children in clinical studies and the use of extrapolation is seen as a useful tool for predicting how a medicine may work in children and adolescents.
Adult clinical data has long been used to estimate dosages and safety profile of medicines prescribed to children but the Agency wants to see a more systematic approach. The new framework sets out when, to what extent, and how extrapolation can be applied and validated.
The draft reflection paper is the outcome of extensive work and consultation with statisticians, experts in modelling and simulation, experts in pharmacology and clinicians.
It forms the basis of a workshop scheduled for 17-18 May where experts and stakeholders will have an opportunity to share their views on the topic. A revised version of the paper is expected to be released for wider public consultation by the end of July.
Separately, the 8th annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will be held in London on 2 June. The aim of the workshop is to promote high-quality clinical studies in children.
