JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

The views expressed here are those of the individual authors
and not necessarily those of the ASA or its board, officers, or staff.


Back to main JSM 2007 Program page

Activity Number: 458
Type: Topic Contributed
Date/Time: Wednesday, August 1, 2007 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #309484
Title: Considerations for the Development of a Set of Noninferiority Trials for a Second-Generation Drug Eluting Stent
Author(s): Joe Bero*+
Companies: Boston Scientific Corporation
Address: One Scimed Place, Maple Grove, MN, 55416,
Keywords: Historical Control ; Propensity Adjusted ; Non-Inferiority Margin
Abstract:

In the development of drug eluting stent programs, next generation stents are expected to perform as well as previously developed versions of a drug eluting stent. Traditional superiority trials are not useful when comparing similar devices. Noninferiority trials offer a method of comparing devices with similar expected efficacy and safety outcomes while allowing for new devices with desirable characteristics to be brought to market. This will be an examination of the development of a set of trials designed to show non-inferiority of a second generation drug eluting stent compared to a first generation drug eluting stent.

  • 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 2007 program

JSM 2007 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.
Revised September, 2007