This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 322
Type: Invited
Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
Sponsor: Committee on Applied Statisticians
Abstract - #306178
Title: A Case Study of Graphics in Clinical Trials: The Role of Statistical Graphics in the Recent Submission/Approval of GSK's Votrient in the United States
Author(s): Michael Durante*+
Companies: GlaxoSmithKline
Address: 1250 S. Collegeville Rd., Collegeville, PA, 19426,
Keywords: graphics ; clinical trials ; visual
Abstract:

Recently GlaxoSmithKline's compound Votrient (pazopanib) was approved by the US Food and Drug Administration for the treatment of advanced renal cell carcinoma (RCC), a form of kidney cancer. The role of statistical graphics were key in the review and approval process, from helping to identify and isolate potential safety signals to highlighting trends in efficacy.

The primary goal of this presentation will be to highlight the role statistical graphics played in this process and continue to play within GSK R&D. Graphical approaches at the patient, study and cross-study level will be shared.


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