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.


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