|
Activity Number:
|
161
|
|
Type:
|
Luncheons
|
|
Date/Time:
|
Monday, August 7, 2006 : 12:30 PM to 1:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #305694 |
|
Title:
|
Statistical Design and Analysis Issues Associated with the Establishment of the Safety and Effectiveness of Medical Devices
|
|
Author(s):
|
Gary Kamer*+
|
|
Companies:
|
U.S. Food and Drug Administration
|
|
Address:
|
1350 Piccard Drive, Suite 100, CDRH/OSB/DBS, Rockville, MD, 20850,
|
|
Keywords:
|
FDA ; clinical ; ethical ; compare
|
|
Abstract:
|
The process of establishing a new medical device as safe and effective enough to be approved by FDA for marketing purposes may require somewhat different design and analysis approaches than would a simple head-to-head comparison of two already-approved treatments. From sample size considerations to interim analysis to interpretation of results, clinical and ethical concerns influence the study design, implementation, and analysis. This roundtable discussion is intended to provide examples and compare competing approaches.
|
- 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 2006 program |
