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Biostatistics Seminar Series

Shuvayu Sen, Ph.D.
Executive Director
Center for Observational and Real World Evidence
Merck Research Laboratories
Kenilworth, NJ

Outcomes research is a scientific discipline that assesses the effect of health care interventions on patients’ health status.  Methods and principles from various disciplines, including statistics, econometrics/ economics, epidemiology and psychology are leveraged in outcomes research.  Outcomes research is used widely for development, implementation and evaluation of health policies including usage decision on health technologies.  Consequentially, it has a significant role in shaping and conduct of drug development and commercialization, whether, it is for go/ no go decision, designing of the clinical programs, or for value assessment.  In this presentation, an overview of this inter-disciplinary research area will be provided including how it is relevant, used and potential roles bio-statisticians can play.  Particular emphasis will be given on how health care payers and drugs/ vaccines developers are leveraging outcomes research.  Further discussion will include broad level view of different methods used including economic evaluation of health technologies and observational studies with examples.  Observational studies constitute a significant part of outcomes research. Existing databases are often leveraged for conducting such studies for efficiency and broad external validity.  A brief overview will be provided on different sources of such real world. Challenges and opportunities in accessing and using them will also be discussed.