JSM 2012 Home

JSM 2012 Online Program

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

Online Program Home

Abstract Details

Activity Number: 245
Type: Contributed
Date/Time: Monday, July 30, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304326
Title: The Stochastic Curtailment of Long-Term Clinical Trials for Noninferiority Case vs. Superiority Case and Its Visualization
Author(s): Shaoyi Li*+
Companies: Celgene Corporation
Address: 62 Briarwood Drive East, Warren, NJ, 07059, United States
Keywords: non-inferiority ; stochastic curtailment ; conditional power ; interim analysis ; futility ; data monitoring
Abstract:

The stochastic curtailment of long-term clinical trials (either sequential or non-sequential) is considered. The conditional means of the B-value at the end of trial given the B-value at interim under different assumptions about the remainder of trial in the context of normally distributed data are analyzed to reveal the quantitative connection between non-inferiority and superiority. The corresponding analytical form of critical B-value or the slope of the trend for stopping the trial at interim for futility is also provided for non-inferiority case. Several useful properties are provided to quantify the lower hurdle of non-inferiority comparing against superiority case. Furthermore, the projection of stochastic curtailment for non-inferiority case is superimposed with the superiority case to illustrate the natural relationship between them. The results are applicable to asymptotically normal such as censored survival data and binomial data.


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 2012 program




2012 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.