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Epi Seminar

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Tuesday, February 7, 2012
Health Sciences K069
3:30 to 4:50pm

The Use of Screening Studies in the Efficient and Accurate Identification of Disease Risk Factors and Effective Therapies

Dr. Emerson
Scott S. Emerson, M.D., Ph.D.
Professor of Biostatistics
University of Washington

Scott S. Emerson, M.D., Ph.D., is Professor of Biostatistics at the University of Washington, where he teaches in the graduate program in Biostatistics, performs research into statistical methods, and collaborates on clinical trials in emergency medicine and cancer. After receiving an undergraduate degree in physics and an M.D., both from the University of Virginia, Dr. Emerson earned a Master's degree in computer science (University of Virginia) and a Ph.D. in Biostatistics (University of Washington). He held faculty positions in the Department of Statistics at the University of Florida and in the Department of Statistics and Arizona Cancer Center at the University of Arizona prior to joining the faculty of the Department of Biostatistics at the University of Washington in 1995.

Dr. Emerson is active in research into methods for the design, conduct, and analysis of clinical trials. A major focus of his research has been in the use of sequential methods, both frequentist and Bayesian, in the monitoring and reporting of clinical trial results. Recent areas of research include the sequential monitoring of studies with primary endpoints that are longitudinal or time to event, adaptive clinical trial designs, noninferiority trials, and nonparametric regression methods, especially as applied to survival data and ROC curve analysis. He has served on a number of government and industry sponsored Data Safety Monitoring Boards (DSMBs), as well as advisory panels to the FDA and NIH.

Abstract:

The Use of Screening Studies in the Efficient and Accurate
Identification of Disease Risk Factors and Effective Therapies

Many clinical investigators have decried the high cost of drug development and the low rate of “positive” studies among phase 3 clinical trials. There have been several initiatives to try to use adaptive designs to speed up this process. In its most general form, an adaptive design uses interim estimates of treatment effect to modify such trial parameters as maximal sample size, eligibility criteria, treatment parameters, or definition of outcomes. I believe such efforts are largely misplaced. In this talk I discuss the key role that scientifically and statistically rigorous study design plays in the process of “drug discovery”—an often iterative process that starts with observational epidemiology and progresses through laboratory science, early phase clinical trials, confirmatory “registrational trials”, and postmarketing surveillance. In particular, I illustrate the fundamental need for an organized approach to screening studies.

Suggested Reading: (TBA)


 

Updated on January 17, 2012