BioCentury
ARTICLE | Regulation

Pediatric push

Why companies should invest in data, alliances to support pediatric extrapolation

August 18, 2018 1:40 AM UTC

FDA has endorsed extrapolation of therapeutic efficacy from adults to children for new drugs to treat partial onset seizures in a draft guidance and is now discussing in public meetings whether the approach can be extended to other indications, such as heart failure and pulmonary arterial hypertension.

Doing so on a large scale may require companies to change the way they study drugs in adult populations. Extrapolation depends upon evidence of similarity between adults and children, but sponsors do not routinely collect the necessary evidence in adult studies. ...