Incorporation of Prior Information in a Clinical Trial: A Reviewer's Perspective
*Manuela Buzoianu, FDA/CDRH 

Keywords: Bayesian trial, medical device, informative prior, hierarchical model

When there is value recognized in the prior clinically relevant data, Bayesian methodology may be adopted in designing a new trial in which such initial data is used as an informative prior. A reason is that the new trial might have smaller sample size or duration by borrowing strength from previous studies. In this talk I will discuss some aspects of informative borrowing in the context of medical devices, focusing on issues to be considered when such Bayesian trial is submitted to support regulatory approval. In particular, I will present some design considerations for the assessment of the Bayesian modeling and the prior and discuss issues such as overly influential prior and divergence of the actual trial results from the prior.