Pediatric Extrapolation OK to Evaluate Safety, ICH Draft Guideline Says
Data from adult trials of a particular drug can be used to evaluate the safety of the drug in a pediatric population, according to a draft guideline released for public comment last week by the International Council on Harmonization (ICH) and the European Medicines Agency (EMA).
Currently, such extrapolation of results from other populations is used to determine the scope and extent of data collection in pediatric trials. The draft guideline ICH E11A — Pediatric Extrapolation confirms that the same concept can be used to determine the safety of using a drug in a pediatric population.
The guideline provides information on the degree to which pediatric extrapolation can be applied and what information should be collected. It addresses disease similarity, drug similarity, similarity of response to treatment, sources and types of existing data, and safety considerations. It also offers considerations for dose selection, model-informed approaches and efficacy when applying pediatric extrapolation.
The draft guideline is intended as a complement to ICH E11(R1) — Clinical Investigation of Medicinal Products in the Pediatric Population.
The deadline for submitting comments on the draft guideline is Aug. 6.
Read the draft guideline: https://bit.ly/37sxdQU.