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Activity Number: 385 - Biomarkers, Endpoint Validation and Other Topics
Type: Contributed
Date/Time: Thursday, August 12, 2021 : 12:00 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #317668
Title: Statistical Consideration of Extrapolation of Adult Efficacy Data to Pediatric Population
Author(s): Cassie Dong* and Yulia Sidi
Companies: Takeda and Takeda
Keywords: Bayesian modelling; mixture model; clinical trial analysis; extrapolation
Abstract:

Pediatric studies for cancer drugs usually have many challenges compared to adult studies due to a small population, ethical reasons, and a lack of a control group. While facing those challenges, an agreed pediatric investigational plan (PIP) or pediatric study plan (PSP) are usually required by EMA and FDA for many drugs. Thus, an efficient utilization of the adult data during both design and analysis stages of pediatric studies is critical to fulfill the PIP/PSP requirement as well as to speed up the drug development for pediatric population. In this talk, we provide practical considerations for developing statistical models of extrapolating adult data to pediatric population in oncology trials at both design and analysis stages. We will focus on Bayesian modelling development and simulations. Illustration examples will be provided along with experiences during submission preparation and regulatory interactions.


Authors who are presenting talks have a * after their name.

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