JSM 2012 Home

JSM 2012 Online Program

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: 165
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305342
Title: Elicitation of Patient Preference for Risk Tolerance of Weight Reduction Devices in Obese Population
Author(s): Martin Ho*+
Companies: FDA/CDRH
Address: 10903 New Hampshire Ave, Silver Spring, MD, , USA
Keywords: Patient Risk Tolerance ; Medical Device ; Preference Elicitation

To explore how to incorporate patient's input in regulatory decision making, FDA's Center for Devices and Radiological Health sponsored the Agency's first patient risk tolerance survey. The purpose of this survey is to elicit the maximum risk tolerance of obese population in exchange for specific level of weight reduction for devices with combinations of attributes such as the safety profiles and diet restrictions. After describing the motivation behind this survey, I will explain the statistical methodology behind the study and discuss the potential role of the result in CDRH's regulatory process.

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.