|
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 #319282
|
|
|
Title:
|
A Constancy-Enforced Noninferiority Design of Medical Device Trials with a Binary Endpoint
|
|
Author(s):
|
Ying Yang* and Yunling Xu and Nelson LU and Yu Zhao
|
|
Companies:
|
FDA/CDRH and FDA/CDRH and FDA/CDRH and FDA
|
|
Keywords:
|
non-inferiority ;
constancy assumption ;
companion test ;
Bayesian
|
|
Abstract:
|
Non-inferiority trials are commonly seen in medical device trials. However, the violation of the constancy assumption could be a serious concern. Two approaches have been proposed to address the impact of violation of the constancy assumption on the validity of a non-inferiority trial: prevention through good trial conduct and adjustment through analysis. In this presentation, we will propose a new approach through including a companion constancy test to enforce the main non-inferiority test so consequently to protect the validity of a non-inferiority trial. We will use an example to illustrate our approach.
|
Authors who are presenting talks have a * after their name.
