This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 442
Type: Invited
Date/Time: Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
Sponsor: Health Policy Statistics Section
Abstract - #306137
Title: Electronic Medical Data, Public Health Decisions, and Statisticians: An FDA Perspective
Author(s): Robert T. O'Neill*+
Companies: FDA
Address: 5600 Fishers Lane, Room 15B33, Rockville, MD, 20857,
Keywords: Sentinel ; observationa medical outcomes partnership ; OMOP ; comparative effectiveness
Abstract:

The recent attention to use of electronic medical records, administrative claims data, insurance data, clinical trial data, electronic record linkage data from multiple sources for the purposes of passive and active signaling of health related risks presents dramatic opportunities for statisticians. But to take advantage of these opportunities, there needs to be an awareness by statisticians of the urgency of being engaged in the process and of learning about these opportunities. The talk will consider how FDA's past experience with clinical trials, standards of evidence, guidance development and its regulatory review process has led to lessons learned and how FDA's recent initiatives such as Sentinel, Safe-Use, the Observational Medical Outcomes Partnership, and the comparative effectiveness initiative should help focus how statisticians can substantially contribute in the future.


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.