The Exploration of Extrapolation of Data from Adults to Pediatric Population.
10.3969/j.issn.1671-7104.2019.05.018
- Author:
Lu LIU
1
;
Xinyue CUI
1
;
Yujing ZHANG
1
;
Wei XU
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
data extrapolation;
guiding principles;
medical devices;
pediatric population
- MeSH:
Child;
China;
Data Collection;
Equipment and Supplies;
Humans;
Technology
- From:
Chinese Journal of Medical Instrumentation
2019;43(5):375-378
- CountryChina
- Language:Chinese
-
Abstract:
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.
