Statistical Study Design Considerations for Medical Device Clinical Studies - from an FDA Reviewer’s Perspective
Heng Li, FDA/CDRH/OSB  Vandana Mukhi, FDA/CDRH/OSB  *Xu Yan, FDA/CDRH 

Keywords: study design, medical device clinical studies

In this talk, study design challenges frequently encountered in the planning stages of medical device clinical studies will be discussed. Issues in three types of study designs will be discussed from a statistical reviewer’s perspective: randomized controlled trials, nonrandomized comparative studies, and single arm studies with performance goals. It provides a framework to aid statisticians and preparers of pre-market submissions in deciding what information to include (and not to include) in the statistical sections