Guideline on extrapolation of data from adults to pediatric population and relevant evaluation considerations
SUN Yan-zhe
GENG Ying
ZHAO De-heng
YANG Zhi-min
Abstract：Pediatric drug shortage and the phenomenon of off-label use caused by it are serious problems disturbing the whole world.Considering the difficulty of conducting clinical trials in pediatric population,extrapolation of data from adults to pediatric population is one of the most effective measures to meet clinical needs for pediatric drugs and ensure drugs' efficacy and safety in a scientific way simultaneously,since this approach could maximally use existing data and reduce unnecessary pediatric trials,thus accelerating pediatric drug development.We analyzed the current situation and the policy background about encouraging pediatric drug development in recent years.Latest guideline about extrapolation of date from adults to pediatric population in China published by CFDA,modes of extrapolation,and several circumstances using data extrapolation in China were introduced.Suggestions on the category of pediatric drugs to be extrapolated as priority,along with the considerations about data needed for evaluation of these drugs were discussed,hoping to improve and guide the development of data extrapolation in China.
Keywords：data extrapolationpediatric drugpediatric populationoff-labelguidelineevaluation
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2154-2158 )