JSM 2005 Online Program

Abstract #303874

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	222
Type:	Topic Contributed
Date/Time:	Tuesday, August 9, 2005 : 8:30 AM to 10:20 AM
Sponsor:	Biopharmaceutical Section
Abstract - #303874
Title:	Intent-to-treat Analyses of Noninferiority Studies
Author(s):	Brian Wiens*+ and William Zhao
Companies:	Amgen, Inc. and Fujisawa Healthcare, Inc.
Address:	One Amgen Center Dr, Thousand Oaks, CA, 93065, United States
Keywords:	Clinical Trials ; Analysis Set ; Active Control
Abstract:	In analyzing clinical trials designed to show superiority of one treatment compared to another, it is standard to use the intent to treat (ITT) subset of study subjects as the primary analysis set. In active-controlled, noninferiority studies, it is standard to place as much or more emphasis on the per protocol (PP) subset of study subjects. We discuss several series of datasets that compare results from ITT and PP analyses. The conclusion generally is that the impact of choice of analysis set in superiority and inferiority studies is minimal. We also discuss barriers to the use of ITT in active-control studies and suggest some strategies to make ITT analyses feasible. While straightforward application of ITT principles may result in difficulties in interpretation of active control studies, we argue that PP analyses do not solve these problems and may make the matter worse. Topics in need of further research are discussed.

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