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Abstract:
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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.
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