|
Activity Number:
|
175
|
|
Type:
|
Roundtables
|
|
Date/Time:
|
Monday, August 3, 2009 : 12:30 PM to 1:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #305395 |
|
Title:
|
The Use of Decision Analysis in Clinical Trials
|
|
Author(s):
|
Telba Irony*+
|
|
Companies:
|
FDA
|
|
Address:
|
Center for Devices and Radiological Health, Rockville, MD, 20850,
|
|
Keywords:
|
decision analysis ; clinical trials ; pre market applications ; post market surveillance ; FDA ; industry
|
|
Abstract:
|
The Center for Devices and Radiological Health at the FDA is investigating the use of quantitative decision analysis in regulating medical devices across the total product life cycle. There is potential to use decision analysis both in the pre market decision making process and in the post market surveillance phase. This round table discussion will explore current uses of mathematical decision analysis in clinical trials in industry, academia and the FDA as well as future uses in post market surveillance.
|
