Summer 2006 Workshop
Held on June 22, 2006 at the Renaissance
Chicago North Shore Hotel.
The 22st Annual Summer Workshop
of the Northeastern Illinois Chapter of the American Statistical Association
was given on the topic of:
Bayesian Clinical Trials
Dr. Scott M. Berry, Berry Consultants, College
The course will
describe recent Bayesian innovations in the design and analysis of clinical
trials. The goals are (i) more efficient clinical trials and clinical
development programs, and (ii) treating patients more effectively, both
those in and outside of trials. The presenter will provide some background
on Bayesian designs for clinical trials and give several case studies of the
adaptive approach used in actual designs and analyses presented to the FDA.
These examples include the possibility of early stopping, seamless phase II
and III trials with sequential sampling, using early endpoints to guide
sample size and adaptive dose finding. The cost savings of such an approach
are usually substantial. The only prerequisite knowledge necessary is a
basic understanding of statistics and of clinical trials.
The course is
designed with two purposes in mind. The first purpose is to inform attendees
of the Bayesian approach to the design of clinical trials. They will learn
new methods for conducting “better” clinical trials. The hope is that a
general knowledge of these new methods and related issues will be
understood. The second purpose is to provide enough detail that someone
involved in the design of clinical trials could conduct a Bayesian clinical
instructional method will be hands-on. The presenter will provide real
examples, with the real issues involved. The best way to understand the
benefits of the Bayesian design is to see how it works in real trials being
conducted. By teaching through these real problems the attendees will see
the potential advantages of the Bayesian design as well as gain the ability
to carry out similar trials.
Berry received his Ph.D. from Carnegie Mellon University (1994) and his B.S.
from the University of Minnesota (1990). He spent 5 years at Texas A&M
University in the Statistics Department. The last five years he has been
consulting for Berry Consultants, where he has designed more than 20 purely
Bayesian clinical trials for pharmaceutical and medical device companies. He
leads the statistical aspects of these trials as well as writing the
software and doing the modeling needed.
Northeastern Illinois Chapter
American Statistical Association