Some form of data extrapolation – either full or partial – was used in making more than 63% of pediatric labeling changes in the United States between 2015 and 2021, according to a new analysis.
The findings, which were published in the Journal of Biopharmaceutical Statistics, revealed that the use of extrapolation increased the rates of new and expanded pediatric indications during the study period.
“Extrapolation is a key tool in pediatric drug development to systematically identify the knowledge gap between the reference population and target population, therefore, to limit the number of pediatric studies and the number of children recruited to each to fill the knowledge gap, along with an ethical argument of not randomizing children to placebo unnecessarily,” wrote Jingjing Ye of BeiGene and colleagues at Servier Pharmaceuticals, UCB Pharma, Flatiron Health, St. Jude Children’s Research Hospital, GlaxoSmithKline, and Pfizer…
