EMA releases preliminary draft on pediatric extrapolation

In a preliminary draft reflection paper released Tuesday, EMA outlined principles for extrapolation of adult clinical data to support pediatric drug approvals. EMA said use of extrapolation may reduce the need to conduct pediatric studies.

In the agency's proposed framework, existing clinical data would be used to identify differences in pharmacokinetics and pharmacodynamics, disease progression and clinical response in patients of different ages. Optimized studies would be designed and performed based on predictions formed from existing data, and their results would be compared to the predictions. ...