The Affordable Health Care Act's Statistical Challenges

• Activity Number: 500
• Type: Invited
• Date/Time: Wednesday, August 7, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Robert Thomas O'Neill*+
• Companies: FDA
• Keywords: observational study ; reliable evidence ; reproducibility ; surveillance ; randomized trials ; outcomes

Abstract

The implementation of the Affordable Health Care Act affords the possibility for many new innovations in how we measure, track, assess, compare and describe health care choices and outcomes as a society. The opportunities cover a range of topics, including safety surveillance;comparative evaluations of therapies,treatments and current medical practices, especially focusing on patient centered outcomes; questions related to real world choices and how to make them in a more informative manner. Statisticians distinguish between inferential and descriptive approaches and focus on reproducibility and reliability of study findings and conclusions derived from the various sources of data that will become available. The talk will cover perspectives on the reliability of evidence to inform decisions derived from observational studies using electronic health records and/or administrative claims data bases, from pragmatic randomized trials using the electronic health record system, from monitoring strategies for safety surveillance, including lessons learned from OMOP and from non-inferiority trials that might be relevant to comparative treatment evaluations.