TL6: Adaptive Designs in Unblinded Studies?
*Jie (Jack) Zhou, FDA CDRH 

Keywords: adaptive design, unblinded study, single arm study

Adaptive designs are starting to gain acceptance in traditional randomized, double blinded and controlled clinical trials. However, the role of adaptive designs in less traditional clinical trial designs is still subject to debate. Could adaptive designs – such as sample size re-estimation - play a role in unblinded studies? Or even single arm studies? What are the practical implications in these scenarios? Please share your stories and opinions.