Conducting a pediatric clinical study is much more challenging compared to its adult counterpart due to relative small pediatric patient population available for clinical studies. This hampers the development of new therapies in this vulnerable population.

The purpose of this round table is to discuss the challenges and potential opportunities related to randomized pediatric clinical trials on: 1) how to leverage the historical pediatric study data from the same type of disease to minimize statistical challenges with limited dose exposure; 2) how to leverage Bayesian hierarchical models to extrapolate pediatric response based on adult data after accounting for covariates to adjust for population differences with much smaller sample size or no pediatric studies conducted; 3) the choice between efficacy and treatment-regimen estimands in dealing with the rescue therapy data; 4) any unique challenges/opportunities to certain therapeutic area.