TL41: Extracting information from observational electronic health and claims data to enhance post-approval medical product safety surveillance
Susan Gruber, Reagan-Udall Foundation for the FDA *Patrick Ryan, Janssen Research and Development Keywords: methods, EHR, observational data The FDA Sentinel Initiative aims to develop and implement a proactive system that will complement existing systems that the Agency has in place to track reports of adverse events linked to the use of its regulated products. One open question is how to effectively harness information in electronic medical records and claims data to improve prescription drug safety monitoring. Research conducted by OHDSI, IMEDS, and Observational Medical Outcomes Partnership (OMOP) scientists sheds light on challenges inherent in analyzing large observational datasets, such as how to appropriately handling bias stemming from treatment by indication, protopathic bias, selection bias, mismeasurement, and unmeasured confounding. Key Question: What are the relative merits of different analytical approaches that can be used either within a risk identification and analysis system or as part of a protocol-based epidemiological evaluation?
|
Key Dates
-
November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC