JSM 2004 - Toronto

Abstract #300738

This is the preliminary program for the 2004 Joint Statistical Meetings in Toronto, Canada. 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, 2004); 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 2004 Program page
Activity Number: 291
Type: Topic Contributed
Date/Time: Wednesday, August 11, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #300738
Title: A Statistical Framework for Characterizing Informed Cross-over in Phase III Clinical Trial
Author(s): Lue Ping Zhao*+
Companies: Fred Hutchinson Cancer Research Center
Address: 1100 Fairview Ave. N, Seattle, WA, 98109,
Keywords: clinical trial ; cross-over ; informed cross-over ; ICO ; likelihood ; failure time
Abstract:

To accelerate the introduction of novel therapy for public consumption, FDA has recently adopted a protocol for conditional approval of a therapeutic agent based on surrogate endpoints, prior to the completion of the Phase III clinical trial. While this protocol is welcomed by industries for accelerating approval process, this conditional approval may be perceived as the "FDA approval" by lay public, resulting in so-called informed cross-over (ICO), i.e., participants in the control arm of the trial may choose to switch from the control arm to the treatment arm, in accordance to their individual prognostic factors at that time, despite the fact that the results with the surrogate endpoint are inconclusive. Analyzing observations from such a trial with ICO, if the percentage of switched subjects is substantial, could be excessively conservative, if the usual intention-to-treat analysis is adopted. Alternative approaches need to be developed for appropriate evaluation of such clinical trial 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 2004 program

JSM 2004 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.
Revised March 2004