JSM 2014 Home
Online Program Home
My Program

Abstract Details

Activity Number: 173
Type: Contributed
Date/Time: Monday, August 4, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #313164 View Presentation
Title: Sample Size Under the Additive Hazards Model
Author(s): Lee McDaniel*+ and Menggang Yu and Richard J. Chappell
Companies: University of Wisconsin-Madison and University of Wisconsin-Madison and University of Wisconsin-Madison
Keywords: Sample Size ; Non-Inferiority ; Additive Hazards
Abstract:

The additive hazards model can be easier to interpret than the proportional hazards model. However, sample size formulas for clinical trials with time to event outcomes are currently based on either the proportional hazards assumption or an assumption of constant hazards. We present sample size formulas for superiority and non-inferiority trials assuming an additive hazards model but no specific distribution. In the non-inferiority case, it is shown that sample size can be slightly reduced if more subjects are randomized to the experimental group than the control group. The non-inferiority sample size formula is then applied to the calculations in the SPORTIF III trial of stroke prevention in atrial fibrillation and the CPORT-E trial of percutaneous coronary intervention. A tool to calculate sample size in a non-inferiority trial under the additive hazards assumption is available on the web at http://www.stat.wisc.edu/ ~mcdaniel/samplesize.html.


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

Back to the full JSM 2014 program




2014 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Professional Development 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.