This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
|
73
|
Type:
|
Contributed
|
Date/Time:
|
Sunday, August 1, 2010 : 4:00 PM to 5:50 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #309064 |
Title:
|
An Evaluation of a Simon 2-Stage Phase II Clinical Trial Design Incorporating Continuous Toxicity Monitoring
|
Author(s):
|
Herman Ray*+ and Shesh Rai
|
Companies:
|
University of Louisville and University of Louisville
|
Address:
|
313 Tipperary Crossing , Shelbyville, KY, 40065,
|
Keywords:
|
Phase II ;
Toxicity
|
Abstract:
|
Phase II clinical trials are usually designed to measure efficacy but safety is also an important endpoint. Previous authors recommended a method to monitor toxic events after each patient is enrolled which is also known as continuously monitoring the toxicity. In this work we investigate combining the usual Simon 2-Stage design to monitor response with the continuous toxicity monitoring methodology. Theoretical justification is given for the nominal size, probability of early termination, and average sample size under the null hypothesis of the combined testing procedure. A series of simulations are preformed to investigate the performance of the combined procedure. In general we see the combined test procedure becomes more conservative as the probability of a person experiencing both a response and toxic event at the same increases.
|
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 2010 program
|
2010 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.