|
Activity Number:
|
367
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Wednesday, August 9, 2006 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #307110 |
|
Title:
|
Evaluating Rolling Dose Designs and Methods
|
|
Author(s):
|
Amit Roy*+ and Frank Shen
|
|
Companies:
|
Bristol-Myers Squibb Company and Bristol-Myers Squibb Company
|
|
Address:
|
Route 206 and Provinceline Road, Princeton, NJ, 08540,
|
|
Keywords:
|
adaptive dose finding ; dose-response ; phase II ; target dose
|
|
Abstract:
|
The FDA has highlighted suboptimal dose selection as a key factor in the decline of successful NDA filings and adverse post-approval findings. An initiative sponsored by PhRMA to address this issue is the Rolling Dose Studies (RDS) Working Group, which investigates the efficiency of an innovative class of adaptive dose-finding designs. In these designs, the number of doses and the allocation of patients to doses are allowed to change during the study by incorporating information in the accruing efficacy and safety data. This presentation will describe results of a comprehensive comparison of a conventional dose-finding design and four alternative methods of designing and implementing RDS. The statistical operating characteristics of these methods were evaluated by simulation, under a variety of trial scenarios and dose-response functions.
|
