Abstract:
|
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.
|