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Demystifying Approaches to the Design and Analysis of Observational Studies of Comparative Effectiveness
Program Code:
143
Date:
Monday, June 25, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Nancy A. Dreyer is Chief of Scientific Affairs and Senior Vice President at Outcome, in Cambridge, Massachusetts and St. Prex, Switzerland. Dreyer and her teams conduct observational research on comparative effectiveness and safety, and quality improvement, and are active in methods development.
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PRESENTER
(S):
Robert Glynn,
Harvard Medical School and Harvard School of Public Health, United States
I am a statistician with over 30 years of experience in medical research. I have worked on the design, interim monitoring, and analysis of numerous clinical trials. I also have considerable experience in methodological issues in pharmacoepidemiology.
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Til Stürmer, University of North Carolina School of Public Health, NC, United States
Currently risk mgt development and scientific lead at EMA, Dr Blackburn has worked in hospital medicine, in the pharmaceutical industry, and was a Specialised Group Leader at EMA. She originally co-developed the course in PhV and PhEPi at LSHTM where she is Hon. Lect. She is President Elect of ISPE
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Description
Observational research is becoming increasingly important for comparative effectiveness research (CER). An overview of epidemiologic methods for design and analysis of observational CER will be presented, along with quality guides from US and Europe.
Learning Objectives:
Recognize the epidemiologic principles and methods that promote the validity of observational comparative effectiveness research (CER)
Identify key guidance documents for the design, analysis and evaluation of observational CER studies, including recent scientific and regulatory guidance.