New online clinical trials course

BROTHER_UNKNOWN@YAHOO.COM (STATISTICS.COM) 2003-11-20 09:09:27

Designing and Conducting Clinical Trials (for Managers)

Course date: February 2004
http://www.statistics.com/content/courses/clinicaltrials/index.html

Statistics.com invites you to participate in a new on-line
distance-learning course for existing and would-be managers and
entrepreneurs of pharmaceutical, medical device, and biologics firms:
Designing and Conducting Clinical Trials (for Managers). The course is
divided into four weekly sessions and incorporates an interactive
bulletin board.

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:

ˇ Designing trials and determining sample size
ˇ Computer-assisted data collection and submission
ˇ Exception handling
ˇ Monitoring
ˇ Budgeting men and materials
ˇ Documentation and reports
ˇ After action review

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, 2003). (The text is available
separately to course participants at a 20% discount.) He was also the
keynote speaker at the 2003 Maastricht conference on "Transnational
Clinical Trials." Following a fourteen-point prescription, he will
take you through all phases of the design, implementation, conduct,
analysis, and after action review of a clinical trial.
An online bulletin board available enables you to interact with the
instructor and your fellow students throughout the course and submit
your own findings for discussion. All students use aliases and their
email addresses and company affiliations are concealed so that the
open interchange of ideas is facilitated.

The course should take 5-10 hours per week. Regular visits to the
course discussion board are required, but you can arrange these at
your own convenience. (Follow-up consultation is available after
completion of the course for an additional fee.)

Who Should Take This Course - Existing and would-be managers and
entrepreneurs of pharmaceutical, medical device, and biologics firms.

Organization of the Course - The course takes place over the Internet,
at statistics.com. Course participants will be given an alias and
access to a private bulletin board on which they will receive course
materials. The board will also serve as a forum for discussion of
ideas and problem solving.

The course is scheduled to take place over four weeks. 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 course leader will provide answers and comments on set weekdays.

The course will be taught in English, given the diversity of
background of the participants. However, participants are encouraged
to contact the course leader with questions or comments in French,
which may be translated and forwarded to the list, whenever relevant.

To enroll - You may register for this course by going to our payment
site and entering your credit card information. NOTE: We will not
charge your card until one week before the course begins. You can
cancel at any time prior to that day.

Register Now for Manager's Guide to Design and Conduct of Clinical
Trials
http://www.statistics.com/content/courses/clinicaltrials/index.html

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

Reserve a Place in this Course
http://www.statistics.com/content/courses/clinicaltrials/index.html