Considerations for Pediatric Trial Designs and Analyses
主 题: Considerations for Pediatric Trial Designs and Analyses
报告人: Dr. PengLiang Zhao (Sanofi Ltd.)
时 间: 2016-12-17 11：00-11：30
地 点: 理科一号楼 1114
Pediatric trials are often conducted to obtain extended marketing exclusivity or to satisfy regulatory requirements. There are many challenges in designing and analyzing pediatric trials arising from special ethical issues and the relatively small accessible patient population. The application of conventional phase 3 trial designs to pediatrics is not realistic in some therapeutic areas. To address this issue we propose various approaches for designing pediatric trials that incorporate data available from adult studies and we also apply the concept of consistency used in multi-regional trials. The performance of these methods is assessed through simulations.