> Designing and Conducting Clinical Trials (for Managers)
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> Course date: March-2004
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> Are you planning for a new clinical trial or are appraising a
just-completed one? 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.  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
> 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 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.
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> 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.
> Who Should Take This Course - Existing and would-be managers and
entrepreneurs of pharmaceutical, medical device, and biologics firms.
> The Instructor - Phillip Good, Ph.D., has been providing on-line
instruction through the auspices of Statistics.com for three years. He is
the author of Common Errors in Statistics and How to Avoid Them (with J.
Hardin, Wiley, 2003), Manager's Guide to Design and Conduct of Clinical
Trials (Wiley, 2002), Applying Statistics in the Courtroom (CRC, 2001),
Resampling Methods (Birkhauser, 2nd ed, 2001), and Permutation Tests
(Springer-Verlag, 2nd ed 2000). Nine other books, 600 plus popular articles,
33 scholarly articles, and sixteen of his short stories are also in print.
Holder of the Ph.D. and A.B. in Mathematical Statistics from the University
of California at Berkeley, he is a former Calloway Professor of Computer
Science at the University of Georgia, Division Head and Professor of Biology
and Physics at West Coast University, and Associate Professor of Applied
Mathematics at Claremont College.
> 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
or
>
> Register for the discount version
> 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
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>    Should the study be performed?
>    Study objectives
>    End points
>    Quality control
>    Study population
>    Timing
>    Closure
> Week 3: Monitoring The Trials
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>    Walk through
>    Site visits
>    Maintaining investigator interest
>    Patient retention
>    Termination and extension
>    Maintaining the budget
>    Interim analyses
> Week 4. Analyzing the Results
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>    Documentation
>    Report coverage
>    Understanding data
>    Exceptions and adverse events
>    Equivalence
>    Bad statistics
>    After action review
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> http://www.statistics.com/content/courses/clinicaltrials/index.html
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