成人数据外推至儿科人群探讨

The Exploration of Extrapolation of Data from Adults to Pediatric Population

儿科用医疗器械不能满足现有的医疗需求,鉴于儿科人群临床试验难以开展,将成人用医疗器械数据外推至儿科人群的方法,可最大化利用现有数据,减少不必要的儿科临床试验,从而加速儿科用器械的研发和上市,保障儿科用器械的临床需求。该文介绍了美国相关指南,并从医疗器械技术审评角度探讨我国成人数据外推至儿科人群,以期为促进我国数据外推的开展提供借鉴。

Pediatric medical devices cannot meet the existing medical needs now.In consideration of the difficulty that clinical trials conducted in pediatric population,reasonable extrapolation of adult device data to pediatric population can maximize the use of existing data,as well as reduce unnecessary clinical trials in pediatric populations.It can also help accelerate the development and marketing of pediatric medical devices and ensure the clinical demand of pediatric devices.We analyzed the related guiding principles in America,and explored the extrapolation of medical device data to pediatric population in China from the perspective of medical device technology evaluation,hoping to provide reference in promoting China's data extrapolation.