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BST 725 – Advanced Clinical Trials I
This is a more rigorous course, intended for doc-
toral students. It covers a variety of statistical topics
relevant to someone working on clinical tria ls, such
as multiple endpoints, surrogate endpoints, nonin-
feriority tests, and Bayesian methods. All members
of the Section on Research Methods and Clinical
Trials share the teaching responsibility for this
course by giving at least one lecture on the topics
for which they have expertise. Hence, this course
allows students who think they may want to do a
dissertation in an area relevant to clinical trials the
opportunity to observe the research interests of the
faculty. In addition to these lectures, faculty mem-
bers who currently manage clinical trials coordinat-
ing centers are brought in to discuss their ongoing
clinical trials. Clinical investigators also provide an
overview of the use and challenges of running clini-
cal trials in their areas of research.
BST 726 – Advanced Clinical Trials II
This is a rigorous course, intended for only biosta-
tistics doctoral students. It has a series of modules,
each focusing on a specific aspect of clinical trials.
While the topics (power analysis, interim monitor-
ing, missing data, and adaptive designs) are cov-
ered in other courses, this course approaches them
from a more mathematical standpoint. In other
words, the intent is not to describe how to com-
pute O’Brien-Fleming stopping boundaries, but
for students to understand the mathematics behind
stopping boundaries and why they control the type
I error rate. In addition to the series of modules,
students are asked to complete a project for which
they select any one of the topics covered in BST
725 or BST 726 and perform a literature review.
They are asked to find a couple of recent papers
related to the topic and prepare both a written and
oral presentation about those papers. The goal is for
them to get an idea of the “cutting edge” research in
these areas and, hopefully, generate ideas for their
dissertation topics.
This new doctoral sequence was officially offered
for the first time during the 2007–2008 academic
year, although preliminary versions of the courses
were offered a few years prior. While it is hard to
gauge the success of the program after a single itera-
tion, the sequence was well-received by students.
For more information about the clinical trials
course sequence or the doctoral program in biosta-
tistics, contact Christopher S. Coffey (ccoffey@uab.
edu), George Howard (ghoward@uab.edu), or Della
Daniel (ddaniel@uab.edu). ■
FEBRUARY 2009 AMSTAT NEWS 11
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