Meeting on 5th February, review of FDA Guidance

The DS SIG went through the FDA Guidance to Industry Draft on Bayesian Methods for Drug and Biological Products. The document lays ground for using Bayesian methods for the analysis of Clinical Trials. This is a huge step forward following Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. It outlines and references requirements for information borrowing, usage of historical data and pediatric extrapolation. It lays out requirements for the determination and acceptance of priors and details how they need to be evaluated for usage in applications to the FDA.