The Department of Mathematics at the University of Dayton presents
The 7th Annual Kenneth C. Schraut Memorial Lecture
Saturday, November 4, 2006
Science Center Auditorium
12:45 - 1:45 pm
The Role of
Biostatistics in Medical Devices:
Making a Difference in People’s Lives Every Day
Dr. Gregory Campbell
Director,
Division of Biostatistics
Center for Devices and Radiological Health
Food and Drug Administration
Abstract:
Statistics plays a key role in society in
general and, in particular, in the fields of biology and medicine. In order for
medical products of any significant risk to be approved for market entry in the
US, the companies must demonstrate that their products are safe and effective.
That is accomplished through clinical trials and other research. Such evidence
for each product is submitted to the Food and Drug Administration and reviewed
by an interdisciplinary team of scientists, including a statistician. The FDA
employs almost 200 statisticians. These biostatisticians review the data,
analysis and interpretation from these clinical studies and provide
recommendations for decisions that FDA makes concerning the marketability of all
kinds of medical products including the wide range of devices. The talk will be
appropriate for current students of mathematics as well as the general public.
After graduating from UD in 1970 with a B.S. in mathematics and a minor in physics, Greg completed a masters in mathematics at Michigan State (where he met his better half, Patricia Forsythe, a graduate of the College of St. Francis in Illinois). They both went to Florida State (much warmer) to get Ph.D.’s, his in Statistics, hers in Mathematics Education. After a stint as a faculty member in the Department of Statistics at Purdue University, Greg came to the National Institutes of Health in Bethesda, Maryland, first in the Laboratory of Statistical and Mathematical Methodology and then as a Section Head in the National Institute of Neurological Disorders and Stroke, where he led a group in the statistical analysis of brain images. He currently directs a group of 40 statisticians in the FDA’s Center for Devices and Radiological Health. The author of 90 scientific publications, Greg is a Fellow of the American Statistical Association and a member of the prestigious Senior Biomedical Research Service in the Department of Health and Human Services.