←Back
44 – Trial Design and Analysis Issues in Medical Devices
Statistical Study Design Considerations for Medical Device Clinical Studies: An FDA Reviewer’s Perspective
Sponsor: Section on Medical Devices and Diagnostics
Keywords: Medical Device, Study Design, Clinical Studies
Heng Li
U.S. Food and Drug Administration
Vandana Mukhi
Food and Drug Administration
Xu Yan
Food and Drug Administration
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.