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Activity Number: 44
Type: Contributed
Date/Time: Sunday, July 31, 2016 : 2:00 PM to 3:50 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #318899 View Presentation
Title: Statistical Study Design Considerations for Medical Device Clinical Studies from an FDA Reviewer's Perspective
Author(s): Xu Yan* and Heng Li and Vandana Mukhi
Companies: FDA and FDA and FDA
Keywords: Medical Device ; Study Design ; Clinical Studies
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.


Authors who are presenting talks have a * after their name.

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