TL8: Bayesian Method, Adaptive Design and Enhanced Quantitative Decision in Early Drug Development
*Tianhui Zhou, Pfizer Inc 


With the recent development on FDA adaptive design guideline and guideline on bayesian method, it's embraced by FDA and statistical community that innovative designs will have great influence in the learning stage of drug development. In reality, there are still resistences to use adaptive design and bayesian method in early phase I or phase II trials.

In this session, we will bring up a few real life examples to share and learn. Questions will be discussed such as what's the most concerns clinical team have; how to influence the team to improve trial design; ways to enhance the decision making in phase I/II trials.