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 - #307621 |
Title:
|
Phase I Studies: Goals, Patient Selection, and Implications for Design
|
Author(s):
|
Paul H. Frankel*+ and Stephen Shibata and Susan Groshen and Jeffrey Longmate and Stella Khoo and Edward Newman
|
Companies:
|
City of Hope and City of Hope and University of Southern California, Norris and City of Hope and City of Hope and City of Hope
|
Address:
|
1500 East Duarte Road, Duarte, CA, 91010-3000,
|
Keywords:
|
Phase I ;
Phase 1 design ;
Phase 1 ;
Cancer ;
Dose escalation ;
survey
|
Abstract:
|
Background: Phase I trials in cancer are often intended to select a dose of a toxic therapy, assuming an unknown but monotonically increasing drug-toxicity and drug-efficacy curve. Statistical designs are often advocated for this situation without a thorough investigation of the clinical processes and goals. Method: A brief anonymous survey was sent to 670 oncologists at major US research institutions. Results: 19 % responded. 66% stated that moderate toxicities would alter subsequent patient selection, conflicting with the statistical assumption of random patient selection. Additional responses suggested that usual Phase I targets and designs, while statistically and operationally convenient, are inconsistent with the clinical intent of the research. Conclusion: Understanding the goals and behaviors of today's Phase I investigators is critical for proper Phase I designs.
|
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.