The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Abstract Details
|
Activity Number:
|
116
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Monday, August 1, 2011 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #301358 |
|
Title:
|
Noninferiority Tests for Binomial Endpoints in Two-Arm Medical Device Trials
|
|
Author(s):
|
Maria Carola Alfaro*+ and Edmund McMullen
|
|
Companies:
|
Boston Scientific Corporation and Boston Scientific Corporation
|
|
Address:
|
4100 Hamline Avenue North, Saint Paul, MN, 55112-5798,
|
|
Keywords:
|
Non-inferiority ;
binomial ;
sample size ;
type I error ;
power
|
|
Abstract:
|
Non-inferiority testing is performed in trials that intend to show that the new device is not inferior to the standard device. A non-inferiority test can be done on binomial and continuous endpoints. Our focus will be non-inferiority tests for the difference of binomial primary endpoints rates in two-sample trials. In this scenario a non-inferiority test is a one-sided test based on the binomial distribution. This test has impact on the sample size, type I error, power and non-inferiority margin of the trial in the design stage, and the conclusion of this test is based on the calculated one-sided p-value of the primary endpoint data. Through real case examples, we will analyze the impact of using different non-inferiority tests in the design stage and on the primary endpoint data through a comparison of estimations of sample size, type I error, power, non-inferiority margin and p-values.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2011 program
|
2011 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.