The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Online Program Home
Abstract Details
Activity Number:
|
393
|
Type:
|
Topic Contributed
|
Date/Time:
|
Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #304490 |
Title:
|
Enhanced Placebo Effect or Other Nontreatment-Specific Effects in Therapeutic Device Studies
|
Author(s):
|
Jianxiong Chu*+
|
Companies:
|
FDA/CDRH
|
Address:
|
8906 Bells Mill Road, Potomac, MD, 20854, United States
|
Keywords:
|
placebo effect ;
medical devices ;
sham control ;
non-inferiority
|
Abstract:
|
Unlike self-administrated drug pills, many therapeutic device treatments involve surgical procedures and more intense interaction between care providers and patients. There are accumulating evidence supporting the notion that non-treatment specific effects such as placebo effect tend to be greater in device studies as compared to drug studies. However, a sham device control is often not feasible or unethical leading to two-arm non-inferiority trial design using current standard care or a previously cleared/approved medical device as the control despite the lack of any randomized superiority trial data in supporting the control treatment. In this talk, the implications of this dilemma for device study design will be discussed, e.g., how to mitigate the risks associated with sham control so that including the sham control could become ethical, how to address the compromised ability to reach a reasonable assurance of device effectiveness from the demonstration of non-inferiority.
|
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 2012 program
|
2012 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.