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: 275
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biometrics Section
Abstract - #306425
Title: Evaluation of Sample Size for Noninferiority Survival Clinical Trials in Endocrine Therapies
Author(s): Naum M. Khutoryansky*+
Companies: Novo Nordisk Inc.
Address: 1100 Campus Road, Princeton, NJ, 08540, United States
Keywords: survival analysis ; sample size calculations ; non-inferiority trials ; cardiovascular events

The problem of the sample size and power determination for time-to-event trials has been studied extensively by many authors. Several methods to solve this problem have been presented under various assumptions regarding the survival, entry and censoring distributions, different approaches in formulating the null and alternative hypotheses. The results presented in some papers on sample size calculation for non-inferiority survival clinical trials were based on the simplified approach when the variance used in determination of the critical region was taken from the alternative hypothesis. The influence of such a simplification on the precision of the sample size calculation was not estimated. The goal of this talk is to compare the simplified approach and the precise approach (when the critical region is based only on the null hypothesis and Type I error). In addition, another approach is considered when the critical regions are determined by the confidence intervals calculated using observed hazards (as recommended in the FDA guidance on cardiovascular events). This talk will present practical examples in evaluation of long-term cardiovascular safety of diabetes therapies.

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.