Abstract #300767

This is the preliminary program for the 2003 Joint Statistical Meetings in San Francisco, California. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 2-5, 2003); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

To View the Program:
You may choose to view all activities of the program or just parts of it at any one time. All activities are arranged by date and time.

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 2003 Program page
JSM 2003 Abstract #300767
Activity Number: 256
Type: Luncheons
Date/Time: Tuesday, August 5, 2003 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300767
Title: Stratified Clinical Trials: Some Food for Thought - THIS LUNCHEON IS SOLD OUT
Author(s): Devan V. Mehrotra*+
Companies: Merck Research Laboratories
Address: Clinical Biostatistics, UN-A102, Blue Bell, PA, 19422,
Keywords: interaction ; Mantel-Haenszel test ; minimum risk weights ; binary data ; multicenter ; prognostic factor
Abstract:

We address some fundamental issues involving stratified comparative clinical trials with emphasis on binary endpoints. First, we differentiate between prognostic and nonprognostic factor stratification when defining the "true overall treatment effect" parameter. Second, we stress the importance of clearly stating the null hypothesis being tested. Third, we review some recently developed alternatives to the popular Mantel-Haenszel procedure and discuss the related issue of stratum weighting. Fourth, we describe how to (and how not to!) test for a treatment by stratum interaction and what to do in the presence of an interaction. Finally, we comment on the issue of random stratum sizes and the resulting impact on commonly reported interval estimates of the "overall treatment effect." Illustrative examples are used to reinforce the key points and support some specific recommendations.

  • 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 2003 program

JSM 2003 For information, contact meetings@amstat.org or phone (703) 684-1221. If you have questions about the Continuing Education program, please contact the Education Department.
Revised March 2003