Online Program Home
  My Program

Abstract Details

Activity Number: 624 - Trial Design and Analysis Issues in Medical Devices
Type: Contributed
Date/Time: Thursday, August 3, 2017 : 8:30 AM to 10:20 AM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #324973
Title: Benefit Risk Assessment in Medical Device Clinical Trials
Author(s): Mourad Atlas* and Chul Ahn
Companies: FDA and FDA
Keywords: Benefit Risk measures ; atrial fibrillation ablation ; blation catether
Abstract:

Evaluating the benefit-risk of medical devices in clinical trials can be difficult task, because the benefit and risk are two distinct variables. While in some cases benefit and risk have the same unit, in general, they are measured in different unit. For example, in the atrial fibrillation ablation studies, preventing or reducing unwanted electrical currents from traveling from the pulmonary veins (large blood vessels that carry blood from the lungs to the left atrium of the heart) to the atria (the upper chambers of the heart) will be considered as benefit, and any major adverse events may be used to assess the risk. In this talk, we propose measures for simultaneously assessing benefits and risks in medical device clinical trials.


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

Back to the full JSM 2017 program

 
 
Copyright © American Statistical Association