FDA Releases Draft of ICH Guidelines on Pediatric Data Extrapolation
The FDA has released as a draft guidance the International Council for Harmonization’s (ICH) pediatric extrapolation guidelines, which aim to reduce the number of pediatric participants needed in trials by drawing conclusions based on data from other trials.
ICH E11A allows extrapolation from adult and other pediatric trials “when it can be assumed that the course of the disease and the expected response to a medicinal product would be sufficiently similar in the pediatric [target] and reference (adult or other pediatric) population.” The council released the draft for public comment in April (CenterWatch Weekly, April 11).
It’s important to evaluate disease similarity between the target population and reference population, the guidelines state, to determine whether there is a level of difference in the disease that would preclude pediatric extrapolation.
“Even if there are differences in the disease, some similarities may be present that would still allow for the use of pediatric extrapolation,” ICH notes.
The council expects to finalize the guidelines in Q2 2024 after all ICH member nations have had a chance to gather public comments.
Read the full draft ICH guidelines here: https://bit.ly/3cslnte.