|
Activity Number:
|
1
|
|
Type:
|
Invited
|
|
Date/Time:
|
Sunday, August 2, 2009 : 2:00 PM to 3:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #302934 |
|
Title:
|
Central Review of Progression-Free Survival in Phase 3 Oncology Trials
|
|
Author(s):
|
Ohad Amit*+ and Frank Mannino
|
|
Companies:
|
GlaxoSmithKline and GlaxoSmithKline
|
|
Address:
|
1250 South Collegeville Road, Collegeville, PA, 19426,
|
|
Keywords:
|
|
|
Abstract:
|
Progression-free survival (PFS) is a key endpoint in the approval of new cancer therapies. One of the key concerns raised with this endpoint is the potential for systematic bias based on local evaluations performed at the site. In many trials with PFS as a primary endpoint, scans are subjected to a blinded independent central review (BICR) in order to confirm the results observed at the site. A 100% independent review of scans can be costly and resource-intensive. We explore a new approach to BICR employing a partial review of scans involving a random subsample of subjects from the trial. The statistical properties for several measures of patient level disagreement between local and central review in the assessment of progression are evaluated. The relationship of these measures to potential bias in the estimation of treatment effect is also evaluated.
|
