This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
|
328
|
Type:
|
Topic Contributed
|
Date/Time:
|
Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #307267 |
Title:
|
Evaluating Cardiovascular Risk in Diabetes Clinical Trials: Lessons Learned from Saxagliptin
|
Author(s):
|
J Mark Donovan*+
|
Companies:
|
Bristol-Myers Squibb
|
Address:
|
311 Pennington-Rocky Hill Road, Pennington, NJ, 08534,
|
Keywords:
|
Multiplicity ;
Meta-analysis ;
diabetes ;
cardiovascular risk
|
Abstract:
|
We discuss a case study of an analysis of major cardiovascular (CV) events for a type 2 diabetes (T2D) drug program, presented at an FDA advisory committee meeting. The program included 8 controlled phase 2/3 trials, durations of 12-102 weeks at analysis. We used several meta-analytic techniques to assess whether there was an unacceptable increase in the CV risk associated with the drug. During FDA review of this drug, several changes took place in the regulatory landscape, including a separate advisory committee meeting discussing CV assessment for all T2D drug and biologic programs, and a new final Guidance was issued relating to CV assessment. We will discuss experiences with particular focus on how changes in the regulatory landscape affected the analysis. Examples include endpoint definition/identification of events, analyses of rare events, and handling of rescue medication.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2010 program
|
2010 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.