|
Activity Number:
|
71
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
|
|
Sponsor:
|
IMS
|
| Abstract - #305519 |
|
Title:
|
Remodified Continual Reassessment Method and the PBTC Experience
|
|
Author(s):
|
Arzu Onar*+ and Mehmet Kocak and James Boyett
|
|
Companies:
|
St. Jude Children's Research Hospital and St. Jude Children's Research Hospital and St. Jude Children's Research Hospital
|
|
Address:
|
, Memphis, TN, 38105-2794,
|
|
Keywords:
|
phase 1 trials ; biostatistics ; oncology ; simulation
|
|
Abstract:
|
The continuous reassessment method (CRM) has served as an appealing alternative to the traditional phase I design due to its model-based approach. It has, however, received harsh criticism as a result of the higher levels of toxicities associated with the original version, which led to various modifications and its subsequent successful application in adult studies. Pediatric clinical trials pose their unique challenges to the application of CRM due mainly to relatively high starting doses associated with pediatric studies. In this talk, we will outline our modifications to the approach and present various simulation results motivated by our experience gained through the Phase I trials within the Pediatric Brain Tumor Consortium.
|
