JSM 2013 Home
Online Program Home
My Program

Abstract Details

Activity Number: 31
Type: Contributed
Date/Time: Sunday, August 4, 2013 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308745
Title: Enrollment and Stopping Rules for Managing Toxicity in Phase II Oncology Trials with Delayed Outcome
Author(s): Guochen Song*+ and Anastasia Ivanova
Companies: Quintiles and Department of Biostatistics, UNC Chapel Hill
Keywords: enrollment rule ; Pocock boundary ; Phase II trial ; Sequential monitoring
Abstract:

Stopping rules for toxicity are routinely used in phase II oncology trials. If the follow-up for toxicity is long, it is desirable to have a stopping rule that uses all toxicity information available, not only information from patients with full follow-up. Further, to prevent excessive toxicity in such trials, an enrollment rule is needed. The enrollment rule informs an investigator about the maximum number of patients that can be enrolled depending on the current enrollment and all available information about toxicity. We give recommendations on how to construct Bayesian and frequentist stopping and enrollment rules to monitor toxicity continuously in Phase II oncology trials with a long follow-up.


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

Back to the full JSM 2013 program




2013 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.

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.