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 - #307215 |
Title:
|
Evaluating Cardiovascular Risk in Diabetes Clinical Trials: An FDA Statistician's Perspective
|
Author(s):
|
Jon Todd Sahlroot*+
|
Companies:
|
FDA
|
Address:
|
10903 New Hampshire Ave, Silver Spring, MD, 20993,
|
Keywords:
|
meta-analysis ;
cardiovascular risk ;
diabetes ;
clinical trial
|
Abstract:
|
In December, 2008, The U.S. Food and Drug Administration (FDA) issued the Final Guidance for Industry "Diabetes Mellitus - Evaluating Cardiovascular Risk in New Anti-diabetic Therapies to Treat Type 2 Diabetes". The Guidance asks sponsors to demonstrate that new therapies for treating type 2 diabetes are not associated with unacceptable levels of cardiovascular (CV) risk. Sponsors are asked to pre-specify statistical methods to evaluate CV risk across controlled trials in the pre-approval development program and, if necessary, post-approval. The statistical recommendations are very general and allow for flexibility in approaches. I will discuss the range of statistical plans submitted to FDA in response to the Guidance and comment on issues such as multiple testing, power calculations and prospective planning of meta-analyses.
|
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.