|
Activity Number:
|
446
|
|
Type:
|
Invited
|
|
Date/Time:
|
Wednesday, August 5, 2009 : 10:30 AM to 12:20 PM
|
|
Sponsor:
|
Statistics in Biopharmaceutical Research Journal
|
| Abstract - #303219 |
|
Title:
|
Flexible Phase I Clinical Trials: Allowing for Nonbinary Toxicity Response and Removal of Other Common Limitations
|
|
Author(s):
|
Richard F. Potthoff*+ and Stephen L. George
|
|
Companies:
|
Duke University Medical Center and Duke University Medical Center
|
|
Address:
|
Cancer Statistical Center, Suite 802, Hock Plaza, 2424 Erwin Road, Durham, NC, 27705,
|
|
Keywords:
|
Bayes ; Beta distribution ; Continual reassessment method ; Dose finding ; Maximum tolerated dose ; Toxicity scoring
|
|
Abstract:
|
Phase I clinical trials are often subject to severe limitations. The most important one is that they typically allow only for binary response---toxic (1) or non-toxic (0)---rather than a range of responses from 0 to 1. They also may not allow a new patient to be treated until results for all previous patients are available. They may assign patients to doses in groups of two or more, rather than individually. They may require the selected dose to be one of a few prespecified doses. The flexible method proposed here addresses these four limitations. It adopts a quasi-Bayesian approach incorporating a logistic dose-response model with two parameters for the mean response. The response at any dose follows a beta distribution, which entails a third parameter. The choice of dose for a patient is based on a utility function.
|
