| |
Back to Program
12/8/2010 (Wednesday) 1:00 PM - 4:00 PM
Session K: Clinical Trial Methodology: Case Studies
Dr. Karl E. Peace, Georgia Southern University
Moderator: Kalyan Ghosh
|
|
A clinical trial is a research study conducted to assess the
utility of an intervention in volunteers. Interventions may
be diagnostic, preventative or treatment in nature and may
include drugs, biologics, medical devices or methods of
screening. Interventions may also include procedures
whose aim is to improve quality of life or to better
understand how the intervention works in volunteers.
Clinical trial methodology (CTM) comprises all methods
required for the protection of participants in a clinical trial
and all methods necessary to provide a valid inference
about the objective of the trial. In short, CTM consists of
all methods necessary to develop and conduct a quality
clinical trial protocol and to provide quality data collection,
biostatistical analyses and a clinical study report while
maintaining the highest standards of ethics and excellence.
Several landmark clinical trials from the presenter’s own
experience that led to regulatory approval of drugs (e.g.
reducing CHD risk, optimal treatment of DU, prevention
of GU, and a parallel bioequivalence trial) will be reviewed
from a case study approach with attention to CTM utilized
|
Karl E. Peace, Ph.D. is Senior Research Scientist, Professor of Biostatistics and the Georgia Cancer Coalition Distinguished Cancer Scholar in the Jiann-Ping Hsu College of Public
|
Back to Program
|
|