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Begins
9th March 2012
Are
you planning for a new
clinical trial or are
appraising a
just-completed one?
A Manager's
Guide to Design and
Conduct of Clinical Trials
covers:
·
Designing
trials and determining
sample size
·
Computer-assisted
data collection and
submission
·
Exception
handling
·
Monitoring
·
Budgeting
men and materials
·
Documentation
and reports
·
After
action review
Who
Should Take This Course: Existing
and would-be managers and
entrepreneurs of
pharmaceutical, medical
device, and biologics
firms
Instructor:
Dr.
Phillip Good, the seasoned
instructor of this
four-week internet course,
has over twenty years
experience in the
pharmaceutical and device
industry.
He is the author of
The Manager's Guide to
Design and Conduct of
Clinical Trials (Wiley,
2002, 2006).
(The text is
available separately to
course participants at a
20% discount.)
He has given tutorials at
the Joint Statistical
Meetings (U.S.) and Deming
Conference, lectured in
Australia, Bulgaria,
Belgium, France, Holland,
Ireland, Slovenia, and
Spain, and was twice a
traveling lecturer for the
American Statistical
Association. This is his
sixth (6th)
year of providing on-line
interactive courses.
Prerequisite:
You should have
familiarity with basic
statistical concepts.
If not, we highly
recommend Introduction
to Statistics via
Resampling Methods and
R/S-Plus (Wiley, 2005) or
Introduction to
Statistics via Resampling
Methods and Excel (Wiley,
2005).
Organization
of the Course:
The course takes place
over the Internet.
During each course week,
you participate at times
of your own choosing -
there are no set times
when you must be
online. Course
participants are given
access to a private
bulletin board that serves
as a forum for discussion
of ideas, problem solving,
and interaction with the
instructor. All
students use aliases and
their email addresses and
company affiliations are
concealed so that the open
interchange of ideas is
facilitated.
The
course is scheduled to
take place over four
weeks, and should require
about 10 hours per week.
At the beginning of each
week, participants receive
the relevant material, in
addition to answers to
exercises from the
previous session. During
the week, participants are
expected to go over the
course materials and work
through exercises.
Discussion among
participants is
encouraged. The instructor
will provide answers and
comments.
Course
Requirements:
The optional text is
Manager's
Guide to Design and
Conduct of Clinical Trials
Wiley, 2nd ed, 2005) by Dr. Good. The previous link allows you to order the
text directly from Wiley.
Wiley typically offers a
15% discount to
statcourse.com customers
during checkout time.
PLEASE ORDER YOUR COPY
BEFORE THE COURSE STARTING
DATE.
Course
Program - The course
is structured as follows:
Week
1: Eight Guidelines
Start with your
reports
Computer-assisted
data entry
Plug the holes as
they arise
Monitor
person-power
Pay only for
results
Lay the groundwork
Plan, do, then
check
Week
2: Trial Design
Should the study be
performed?
Study objectives
End points
Quality control
Study population
Timing
Closure
Week
3: Monitoring The Trials
Walk through
Site visits
Maintaining
investigator interest
Patient retention
Termination and
extension
Maintaining the
budget
Interim analyses
Week
4. Analyzing the Results
Documentation
Report coverage
Understanding data
Exceptions and
adverse events
Equivalence
Bad statistics
After action review
Cost:
$345
per participant.
($259
for each additional person
at the same firm,
institution or government
office.)
Students, faculty
and research workers at
academic institutions are
eligible for a discount.
Just send an email from
your academic or
institutional email
account to courses@statcourse.com
to receive a discount
coupon worth $45 toward
the cost of the
course.
Immediately
after your payment is
credited, you will receive
an email giving you sign
up instructions, and the
web address (URL) of the
course material.
Note that you will not be
able to access this
address until the start
date of the course. |
