JSM 2013 Home
Online Program Home
My Program

Abstract Details

Activity Number: 355
Type: Contributed
Date/Time: Tuesday, August 6, 2013 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #308608
Title: A Comparison of Group Sequential Strategies for Three-Arm Noninferiority Trials
Author(s): Toshimitsu Ochiai*+ and Toshifumi Sugitani and Yuko Ohno and Toshimitsu Hamasaki
Companies: Shionogi & Co., Ltd. and Osaka University Graduate School of Medicine and Osaka University Graduate School of Medicine and Osaka University Graduate School of Medicine
Keywords: Three-arm non-inferiority trial ; Group sequential design ; Power ; Sample size estimation ; Predicted intervals
Abstract:

When designing a clinical trial to show that an experimental intervention is effective, a three-arm non-inferiority design including both a placebo and active controls may be optimal because assay sensitivity (AS) can be assessed within the trial and the non-inferiority (NI) of experimental intervention to active control can be evaluated. In this presentation, we consider two scenarios for the assessment of NI and AS in three-arm non-inferiority trials within the framework of group sequential designs. The statistical significance for NI and AS is established jointly at the same interim point of the trial in one scenario, and is demonstrated at any interim point until the end of the trial in the other scenario. We define the power for each scenario and outline sample size calculation including the maximum and expected numbers. A simulation study is then performed to illustrate the aspects of each scenario, which are compared with a conventional fixed design. Furthermore, we discuss the use of predicted intervals as a flexible and practical tool for quantitative monitoring of the potential effect size estimates and associated precision for NI and AS.


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

Back to the full JSM 2013 program




2013 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.

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

ASA Meetings Department  •  732 North Washington Street, Alexandria, VA 22314  •  (703) 684-1221  •  meetings@amstat.org
Copyright © American Statistical Association.